Statistical Programming Technical Manager

Clinical Dev

icon-location-marker Princeton - NJ - US
Posted 24 days ago Full_time R1516924

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

 

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary

The Global Biometric Sciences (GBS) Statistical Programming Technical Manager provides functional expertise and leadership to Statistical Programming and Data Science (SP&DS) colleagues while delivering comprehensive programming expertise to clinical project teams in support of development, regulatory approval, and market acceptance of Bristol-Myers Squibb (BMS) products. This position is primarily responsible for the designing, developing and implementing technical solutions for integrating, analyzing and reporting clinical data. Includes using SAS, R, and other statistical software packages.

Responsibilities

  • Ensures quality of GBS deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs and work practices
  • Provides comprehensive programming leadership and support to clinical project teams, including deployment of programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, corporate and departmental SOPs and work practices
  • Drives the development and implementation of innovative strategies and technologies for clinical trial programming
  • Provides technical guidance to vendors around project standards, programming conventions/specifications and programming practices to ensure efficient and integrated project computing strategies
  • Reviews planning documents (e.g. statistical analysis plans, data presentation plans, data review plans) to ensure alignment with development team objectives
  • These reviews focus on clarity, integrity and completeness of programming assumptions and requirements, and ensure compliance with standards
  • Develops unambiguous and robust programming specifications for internal and external programming work
  • Independently develops, troubleshoots,  and maintains complex programs and utilities in accordance with predefined specifications and BMS standards
  • Understands software development methodologies and appropriately applies those methodologies
  • Identifies opportunities for increased efficiency and consistency within GBS and  provides leadership and support to improvement initiatives

Qualifications

  • Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience
  • Minimum of 6 years clinical/statistical programming experience within pharmaceutical clinical development
  • Extensive knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements (e.g. CDISC, electronic data package submissions, SCS)
  • Broad expertise in statistical programming and developing computing strategies for statistical analysis & reporting within the pharmaceutical industry
  • Extensive knowledge of SAS software (i.e. Base, Stat, Graph components) R and general computing techniques
  • Ability to work successfully within cross-functional teams leading by developing and maintaining successful partnerships
  • Demonstrated ability to flexible and adapt quickly to changing needs within an organization
  • Demonstrated ability to organize multiple work assignments and establish priorities
  • Communicates proactively and effectively; excellent verbal and written communications skills
  • US military experience will be considered towards industry and professional experience requirements

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 the resources to pursue their goals, both at work and in their personal lives.