Job Details

Associate Director, Biostatistics

Clinical Dev

icon-location-marker Princeton - NJ - US
icon-location-marker Berkeley Heights - NJ
icon-location-marker San Diego - CA - US
Posted 32 days ago Full_time R1545809

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 Summary

The Associate Director of Biostatistics is a member of cross-functional Development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, the Associate Director of Biostatistics can have responsibilities for supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the Biostatistics indication/asset Lead, and other cross functional team members.

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.