Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary / Objective：

Responsible for the oversight of the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

Act as one of the points of contact at a Site level for internal and external stakeholders.

Position Responsibilities

• Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders.

• Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.

• Develop Site relationships (incl. Contract Research Organization related issue management and non- registrational /Investigator Sponsored Research Studies).

• Recommends sites during the site feasibility and/or site selection process

• Conducts pre-study visit as appropriate.

• Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation.

• Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, BMS procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable.

• Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.

• While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions.

• Serve as a point of contact for Sites.

• Provides trainings to sites.

• Performs site closure activities when all required protocol visits and follow-up are completed.

• Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.

• Ensures completeness and quality of data submitted from study sites.

• Ensures eCRF data is available and current by using the available systems to follow site activities. Oversees activities of site personnel over whom there is no direct authority.

• Motivates/influences the site to meet study objectives, including enrolment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method.

• Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents, and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented.

• Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions.

• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner.

• May support Ethics Committee submission, ICF review, collection of documents to/from site.

• May support ensuring access to eDC and BMS / vendor systems is available for clinical trial site personnel.

• May support equipment calibration and tracking.

• May support preparation of Study Initiation Visit materials.

• May support coordination and ensure database lock timelines are met as required locally.

Senior Level Expectations:

• Proactively identify and resolve potential problems at both site and country level.

• Engage with Clinical Trial Manager and/or line management to assist in the resolution of more complex issues.

• Proactively seek to enhance communication skills with both internal (Global level) and all relevant external parties and coaches others to do the same.

• Contribute significantly to study team and coaches site staff to enhance site and hub performance.

• Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations.

• May assist line management with conducting monitoring authorizations and ongoing assessments

Degree Requirements：

Bachelors or Masters degree required. Field of study within life sciences or equivalent.

Experience Requirements：

• Associate Clinical Trial Monitor: 1 year of relevant clinical research experience and/or relevant educational experience.

• Clinical Trial Monitor: 2-3 years of relevant clinical research experience, able to work independently.

• Senior Clinical Trial Monitor: At least 5 years of monitoring experience. Demonstrate leadership skill, mentor and coach capability.

• Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred.

• Experience in the drug discovery/development process.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Purpose

The Associate Director, Biostatistics is a core member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, preparation of regulatory submissions and publications. Statisticians develop collaborative relationships and work effectively with the Global Biometric Sciences (GBS) Lead, the GBS Planning and Execution Lead, statistical programmers, external partners, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team.

Primary Responsibilities

• Core member of an EDT and key sub-teams. Contributes to all aspects of the development strategy.

• Independently leads the development and execution of statistical aspects for one or more clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications.

• Participates in development strategy, protocols and analysis plans reviews.

• Participates in continuous improvement initiatives.

• Invests in knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments that impact the development teams.

• Engages as a matrix team member on protocol teams as a scientific partner in the drug development process.

• Ability to present summary data and analyses to key stakeholders in a clear, concise, complete and transparent manner.

• Possesses technical knowledge of statistical methodology and ability to appropriately apply it in trial design and data analysis for clear, concise, high-quality results.

• Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.

Education/Experience

• PhD degree in Statistics or Biostatistics or Master’s degree with 7+ years' of relevant Pharmaceutical/R&D or other related experience, including supporting regulatory filings.

• Demonstrated knowledge of statistical / clinical trials methodology as it relates to clinical development.

• Relevant prior data analysis planning, execution and delivery experience.

• Excellent verbal and written communications skills.

• Ability to be flexible and adapt quickly to the changing needs of the organization.

• strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement, including the resolution of conflicts or their appropriate escalation

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Key Responsibilities

• Collaborates in design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contributes to project development strategy
• Defends protocols and analysis plans at internal governance reviews and provides independent reviews of complex protocols.
• Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents
• Presents summary data and analyses results, in a clear, concise, complete, and transparent manner
• Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information
• Manages multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area
• Applies extensive knowledge of statistical / clinical trials methodology as it relates to clinical development
• Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments with demonstrated application to study design.
• Effectively engages as a matrix team member on project teams, to act as a scientific and strategic partner in the drug development process
• Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable
• Contributes to external and internal statistical community of practice
• Develops & advises team members
• Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS.
• Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.

Applicable to people managers 

• Effectively engages as an employee advocate and management coach/mentor to team members - both internally and externally
• Provides leadership to empower and develop the team.
• Provides guidance to employee's development plans and carries out performance review and feedback. develops performance metrics for staff.

Qualifications & Experience

• PhD (6+ years’ experience) or MS (8+ years’ experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience
• Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
• Great interpersonal, communication, writing and organizational skills
• Expertise in statistical/clinical trials methodology as it related to clinical development and ability to apply to relevant clinical development framework
• Good understanding of regulatory landscape and experience with participating in regulatory interactions
• Demonstrate collaboration, organizational/ leadership abilities, and interpersonal skills
• Demonstrate ability to plan, organize, and prioritize multiple work assignments, and strong project management skills
• People manager experience is preferred (for people manager position only)

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

• Develop, implement and manage world-class learning solutions in support of the GMP Training objectives and to ensure regulatory compliance.
• Collaborate with functional area representatives, subject matter experts (SMEs) and cross-functional teams to develop and implement key learning strategies and programs.
• Provide training expertise and consultation in support of the GMP Training model and process.
• Design and develop training courses and determine appropriate methodology.
• Lead cross-functional training project teams in the creation of strategic training initiatives.
• Participate in BMS cross-site training project teams.
• Directs, manages, and leads Training & Development process design, development, implementation, and evaluation at the site (develop curriculum, design and implement systems for applied learning and reinforcement, train and develop site resources, etc.) to ensure performance improvement.
• Leads the Train the Trainer Program for the Site to ensure the development of trainers in different organizational areas.
• Leads the Site on the Job Qualification Training Program and provides advice to ensure compliance with Corporate policies.
• Monitors and audits the areas Qualification training programs (QC Laboratories, Warehouse, Manufacturing and Utilities).
• Provides support in creating and reviewing qualification skills modules.
• Identifies and updates operators “Learning Plans” for qualifications tasks to ensure a systematic approach and Compliance.
• Aligns the qualification training program needs with the requirement of functional areas.
• Diagnoses and assesses organizational needs and gaps in processes, systems and learning.
• Serves as an internal consultant to management, focused on targeting performance improvement needs, providing feedback, and recommending training
• and non-training solutions, including human reliability and investigations of human errors.
• Actively builds collaborative relationships partnerships with all levels of the organization in the identification and implementation of learning solutions.
• Plans and co-facilitates classroom training sessions and learning sessions focusing on a wide variety of topics.
• Provide guidance, expertise and consulting to functional managers and SMEs in the assessment of training needs, the design of appropriate training, development, and implementation, and the measurement of training effectiveness.
• Demonstrates initiative, teamwork, commitment and follow-through with all training initiatives.
• Works independently and if issues or problems are identified, works with Management to resolve.
• May work on assignments that are complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
• Performs as Technical Training function SME during audits.
• Ensures training expenses are within the approved budget.
• Performs as back up of the area Director as required.

• Bachelor’s Degree in Instructional Design, Adult Education, Human Resources, Business Administration, Organizational Development, Industrial Psychology or a related field.  A Master’s degree preferred in a development/training discipline.
• A minimum of 7 years of experience in learning and development within the pharmaceutical manufacturing industry or a related field is preferred, including 5 years supervising learning and development professionals.
• Experience leading a team whose focus is on designing effective employee training initiatives, programs, and knowledge management.
•  Strong understanding of adult learning theory and a variety of learning methodologies.
•  Experience with the ADDIE model or other instructional design methodologies.
•  Highly developed skills in the design development and assessment of training programs.
•  Ability to identify training needs, develop training content, and deliver training programs.
•  Strong project management and organizational skills.
•  Experience with Skills Qualification programs for critical positions.
• Experience developing training materials for OJT qualification process.
•  In-depth knowledge of technical training curriculum and design processes.
•   Strong knowledge in Root Cause evaluation associated to human error.
•  Experience using LMS and eLearning tools.
• Experience working with manufacturing documents, change controls, deviations and regulatory documentation.
• Proficient in cGMP’s, Safety and Regulatory Agencies Regulations, documentation practices and manufacturing process. 
•  Highly developed communication, presentation, organizational, interpersonal skills, leadership and planning skills.
•  Demonstrated ability to write clearly and concisely.
•  Ability to balance multiple assignments in a fast-paced environment.
• Ability to drive collaborations across functions to accomplish objectives and to work collaboratively with all employees at all levels.
•  Good computer skills including proficiency with common business software such as MS Office including database management tools.
• Demonstrates strong problem-solving and decision-making skills.
• Bilingual Spanish/English.  Both written and verbal are required.
• Ability to establish and maintain excellent working relationship with a variety of internal and external customers.
• Willing to work irregular hours, rotating shifts, weekends and holidays.

BMS BM

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position: Manufacturing Operations, Senior Team Leader (3rd shift)

Location: Humacao - PR

• Leads a Manufacturing Production area Team to ensure that production, competitive cost, quality/regulatory, customer service requirements are met or exceeded.
•  Plans and organizes the area work to achieve a High Performing Team environment.  Manages the assigned operations area people staffing, performance assessment, merit increase /annual performance bonus, counseling/coaching/disciplinary & corrective actions, and takes action for performance improvement as well as career development.
• Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of Manufacturing Operations area. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Determines production schedule, updates schedule’s board, communicates daily schedule performance to team members and communicates the shift production information with other shifts leaders. Reduces cycle times and optimizes production scheduling by the use of innovation tools including.
• Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation.  
• Trains the Team on any necessary compliance and quality requirements related with the area or the business. Reviews Batch Records (Paper/Electronic) and manages discrepancies.
• Collaborates effectively with other functional SMEs to ensure production goals are met and investigations are expeditiously completed. Participates in and may lead continuous improvement initiatives applying tools like: 5S, LEAN manufacturing and Six Sigma to improve quality, cost, safety and cycle time. Performs administrative duties for the assigned area that include team members attendance monitoring, attendance timecards approval, vacations scheduling and approval and overtime coordination to meet production requirements.
• Provides, in coordination with other departments, the guidance and resources to support technology transfer activities, equipment qualification, process validation, troubleshooting, clinical lots production, and process optimization.
• Participates in quality and safety investigations. Provides support to the regulatory affair reports, customer complaints, and area exception reports (e.g., Quality Investigation Reports, Quality Complimentary Reports, Change Request Forms, etc.).
• Ensures that area Team members comply with the established learning curriculum to achieve proper knowledge transfer/acquisition. Participates actively as a key contact member of the OSD operations areas in the internal and external audits.
•  Provides input in the creation and revision of SOP’s, protocols, batch records and related documents to assure compliance with cGMP’s, company policies / procedures and documentation practices. Maintains control of all environmental/safety issues in the OSD Manufacturing operation areas. Serves as the back-up of the OSD Operations Manufacturing Manager, as requested.
•  Maintains accurate tracking records and provides timely feedback to Manager regarding status of costs in the assigned area relating to overtime and waste. 
•  Monitors usage and expenses related to supplies and labor costs in the work area.  Implements shop floor continuous improvement practices to meet financial standards. Promotes and models the BMS Core Behaviors, facilitating teamwork, providing coaching and feedback.

• BS  Degree  in  Engineering  /Biology/  Chemistry,  Pharmacy  or  related  sciences  with  three  (3)  years  of  experience  in pharmaceutical  OSD  manufacturing  processes;  or  BBA  Degree  in  Business  Administration  with  five  (5)  years  of experience in pharmaceutical OSD manufacturing processes.
•  Proven in-depth technical knowledge on Oral Solid Dosage Manufacturing processes•Proficient in regulatory / compliance areas of cGMPs, FDA regulations, EHS.
• Basic understanding of product cost structure, budgeting process and spending.
• Three (3) years of experience in a supervisory / managerial position.
• One  (1)  year  experience  in  a  very  highly  automated  manufacturing  operations  environment  (Electronic  Batch Records/NIR-PAT Technology).
• Proven strong leadership skills managing performance to the attainment of high performing team •Knowledge and experience implementing Six Sigma and Lean Manufacturing.
• Strong business sense.
• Sense of urgency, accountability and agile decision making.
• Understanding of and capability to support financial and total quality/safety objectives.
• Assertiveness and uncompromising attitude with regard to the quality standardsThis is a list —­ style: List Paragraph.

• Exposed to various working environments which may potentially expose the incumbent, for which protective equipment is required.
• Some travel required to attend meetings and trainings.

BMSBL

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Primary Responsibilities:

• Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate

• Contributes to preparation of  the development strategy that will allow for effective and safe utilization of the product

• Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use.  Develops trial designs that address study objectives that will support regulatory approval and market access.

• Translates scientific questions into statistical terms and statistical concepts into layman terms

• Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information

• Ensures that all analyses conducted have clearly articulated hypotheses  associated with them and that the trial design and data collected support conducting the analysis

• Communicates effectively with clinical and regulatory partners and  external opinion leaders

• Builds the external reputation of BMS R&D via external interactions through collaborations with alliance partners, academic and government research organizations and through conference participation

• Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms,  clinical study reports, associated publications and other study level specification documents

• Exercises cost-disciplined science in  sizing of the trials and in the planning for the analyses to be conducted

• Compliant with BMS processes and SOPs, global and project standards, and responsible for quality of deliverables

• Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information

• Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents  and scientific articles

• Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.

• Drives alignment at team (IPT) level, and escalates lack of team alignment to the GBS Lead for resolution

• Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions

• Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.

• Keeps up-to-date with state-of-the art applied statistical methodology

Impact:

The Biostatistician is responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level. These contributions lead to better understanding of the asset being studied, improved development decisions, and an increased likelihood of regulatory and market success. This role has significant stakeholder management responsibility with business partners on their team. The biostatistician has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data. This person may interact with external vendors, key opinion leaders and regulatory agencies.

Success Factors: Effectively demonstrates fully functioning capability in the following areas:

• Urgency

• Innovation

• Passion

• Inclusion

• Accountability

• Integrity

GBS Leadership Success Factors:

• Leading and Managing Change

• Influence and Impact Relationships

• Decision Making

• Building a Learning Environment

• Emotional Intelligence

• Managing and Developing Performance

Education/Experience:

• Significant academic training in statistics, biostatistics or relevant areas of study. PhD degree in statistics or biostatistics or Master’s degree with relevant experience required.

•  Understanding of the application of biostatistics to medical/clinical trials data.

• Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals

• Excellent verbal and written communications skills.

• Ability to be flexible and adapt quickly to the changing needs of the organization.

• Ability to organize multiple work assignments and establish priorities.

• Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Objective:

Provide strategic direction to effectively drive the development and implementation of the regulatory documentation strategy to deliver key R&D business objectives, support “speed to patient”, and facilitate submissions of investigational applications for early development of new molecular entities (NMEs) in the intended key markets. Provide leadership in planning and supporting the regulatory submission(s) by Early Development teams (EDT), and align with Early Development Committee (EDC) on prioritization and execution of overall global development strategy.

Expected Areas of Competence:

Submission Strategy:

1. Develops and communicates strategic direction for worldwide regulatory documentation in support of investigational applications in alignment with BMS R&D goals and objectives.

2. Implements regulatory documentation standards that support speed and consistency of regulatory submissions across all assets and geographies.

3. Drives regulatory documentation strategy and processes to ensure timely submission of investigational applications for early development of NMEs in the intended key markets in accordance with BMS R&D objectives and commercial priority.

4. Facilitate transition between early and full development with emphasis on speed-to-patient and high-velocity projects

5. Champions the GSRD organization across multiple functions and identifies meaningful synergies.

6. Identifies opportunities to participate / influence regulatory policy and climate with respect to documentation and dossier presentation in support of project goals and BMS preferences.

7. Applies knowledge of internal and external guidances in providing feedback to the EDTs on issues related to regulatory documentation.

Execution:

1. Proactively addresses business need, prioritization of regulatory submissions, and allocates resources to meet strategic BMS R&D early development goals.

2. Contributes to the development of effective documentation processes and standards; ensures (i) implementation of the processes that support EDT goals and (ii) maintenance of BMS R&D good documentation principles and standards.

3. Implements major BMS R&D-wide change management initiative to improve cycle time and quality of regulatory documentation for global investigational applications.

4. Reviews project-specific story boards, prototypes, and model documents, as needed.

5. Advises and authors complex clinical documents (e.g. IBs, Phase 1/2 clinical study reports, high-level summary documents, background documents) for timely submission to health authorities worldwide

6. Proactively reviews progress against the investigational application/dossier plans, leads group members in identifying opportunities and threats in terms of documentation activities, and drives potential solutions with key team members.

7. In conjunction with appropriate disciplines, identifies and ensures management of external documentation when required for in-licensed asset packages.

8. Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents

Knowledge Desired:

(3-5 pre-hire areas of knowledge)

1. PhD/MD/PharmD in a relevant scientific discipline, or MS/BS with thorough understanding of scientific principles and hypothesis testing and at least 5 years of pharmaceutical regulatory documentation.

2. Analyzed and interpreted complex data from a broad range of scientific disciplines, including pharmacokinetics, pharmacodynamics, ECG, immunogenicity, bioanalytical and pediatric reporting requirements.

3. Thorough understanding of global pharmaceutical drug development, both non clinical and clinical, and requirements for submission of regulatory dossiers for investigational applications to global health authorities.

4. Broad knowledge of the pharmaceutical industry and major worldwide regulatory agencies, including their process and organization.

5. Thorough understanding of the US and EU regulatory requirements; good understanding of Japanese and other major international regulatory requirements and procedures with an emphasis on early development deliverables to facilitate global readiness of full development program.

Experiences Desired:

(5-7 pre-hire ideal experiences)

1. Prior early development clinical trial experience preferred, with an emphasis on PK, PD, ECG, immunogenicity, bioanalytical, and pediatric reporting requirements.

2. At least three major submissions (IND/CTx/NDA/MAA/J-NDA), preferably in different therapeutic areas and a strong depth and breadth of knowledge of the submission process and significant experience in writing high-level summary documents for global registrations.

3. Exhibits solid behaviors in cross-functional collaboration and communication.

4. Experience working with FDA/EMEA/PMDA/TGA/SFDA on a wide range of issues including responding to questions, project-related meetings, and Advisory Committee meetings

5. Experience in the areas of state-of-the-art documentation processes and technology.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Purpose

The Associate Director, Biostatistics is a core member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, preparation of regulatory submissions and publications. Statisticians develop collaborative relationships and work effectively with the Global Biometric Sciences (GBS) Lead, the GBS Planning and Execution Lead, statistical programmers, external partners, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team.

Primary Responsibilities

• Core member of an EDT and key sub-teams. Contributes to all aspects of the development strategy.

• Independently leads the development and execution of statistical aspects for one or more clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications.

• Participates in development strategy, protocols and analysis plans reviews.

• Participates in continuous improvement initiatives.

• Invests in knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments that impact the development teams.

• Engages as a matrix team member on protocol teams as a scientific partner in the drug development process.

• Ability to present summary data and analyses to key stakeholders in a clear, concise, complete and transparent manner.

• Possesses technical knowledge of statistical methodology and ability to appropriately apply it in trial design and data analysis for clear, concise, high-quality results.

• Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.

Education/Experience

• PhD degree in Statistics or Biostatistics or Master’s degree with 7+ years' of relevant Pharmaceutical/R&D or other related experience, including supporting regulatory filings.

• Demonstrated knowledge of statistical / clinical trials methodology as it relates to clinical development.

• Relevant prior data analysis planning, execution and delivery experience.

• Excellent verbal and written communications skills.

• Ability to be flexible and adapt quickly to the changing needs of the organization.

• strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement, including the resolution of conflicts or their appropriate escalation

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.