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 GBDS Biostatistics Lead, GBDS medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team.
Key Responsibilities
- 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 lay terms.
- 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 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 statistical deliverables, e.g., tables, listings, and figures.
- Takes accountability for ensuring quality in all planning, design and execution of the assigned protocol or project.
- 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 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 relevant questions.
- Keeps up to date with state-of-the art applied statistical methodology
Qualifications & 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.
- 3 years Pharmaceutical/Drug Development or other related experience
- 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 organize multiple work assignments and establish priorities.
- This position may require up to 20% domestic and/or international business travel
BMS has an occupancy structure that determines where an employee is required to conduct their work. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive 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.
#J-18808-Ljbffr…