Sr. Manager, Biostatistics

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.

HR Job Title

Senior Manager

Division

Global Drug Development (GDD) /

Global Biometrics & Data Sciences (GBDS)

Functional Area Description

To develop and apply biometric methods to aid design, conduct, analysis, interpretation and publication of scientific investigation and to ensure valid conclusions, thereby facilitating drug discovery and development, enabling regulatory approval and market acceptance, and supporting safe and effective use of BMS products.

Position Summary

The biostatistician 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, biostatisticians can have responsibilities for integrated summaries and/or supporting a particular indication of an asset.  These individuals develop collaborative relationships and work effectively with the GBS Biostatistics Lead, the GBS Planning and Execution Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team. Biostatisticians are individual contributors and report to a GBS Lead.

Position 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.  Develop 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 GBDS Lead for resolution.
• Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer releva