Senior Manager, Biostatistics

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.

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, and 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 through collaborations with alliance partners, academic and government research organizations, and 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 planning for the analyses to be conducted.
• Complies with BMS processes and SOPs, global and project standards, and is responsible for the 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 the team level and escalates lack of 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 a master’s degree with relevant experience required.
• More than 3 years of 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 communication skills.
• Ability to organize multiple work assignments and establish priorities.
• May require up to 20% domestic and/or international business travel.

Benefits & Opportunities

BMS offers competitive benefits, services, and programs to support employees in their professional and personal lives.

Equal Employment Opportunity

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

R1601175: Senior Manager, Biostatistics

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