Senior Manager, Biostatistics

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 may have responsibilities for integrated summaries and/or supporting a particular indication of an asset. The role involves collaborating with the GBDS Biostatistics Lead, GBDS medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team.

Key Responsibilities

• Contribute to the development strategy to enable effective and safe product utilization.
• Drive the design of innovative and efficient clinical trials, including selection of study populations and endpoints.
• Develop trial designs that support regulatory approval and market access.
• Translate scientific questions into statistical terms and vice versa.
• Ensure analyses have clearly articulated hypotheses and that trial design and data support those analyses.
• Communicate effectively with clinical and regulatory partners and external opinion leaders.
• Build external reputation through collaborations with alliance partners, academic and government research organizations, and conference participation.
• Author and/or review protocol synopsis, protocol, statistical analysis plan, data presentation plan, case report forms, clinical study reports, associated publications, and other study level specification documents.
• Exercise cost disciplined science in trial sizing and analysis planning.
• Maintain compliance with BMS processes and SOPs, and ensure quality of statistical deliverables (tables, listings, figures).
• Assume accountability for quality in all planning, design and execution of assigned protocols or projects.
• Collaborate with clinicians and medical writers to prepare summaries for regulatory documents and scientific articles.
• Lead interpretation of results, development of key messages, and communication to the development team.
• Drive team alignment and, when needed, elevate misalignment to the GBDS Lead.
• Provide statistical consultation for ad hoc analysis requests, including design of appropriate analyses.
• Stay current with state of the art applied statistical methodology.

Qualifications & Experience

• Significant academic training in statistics, biostatistics or a related field.
• PhD in statistics or biostatistics, or a Master's degree with relevant experience.
• More than 3 years of pharmaceutical/drug development or related experience.
• Understanding of the application of biostatistics to medical/clinical trials data.
• Ability to work successfully within cross functional teams to achieve global regulatory filings and approvals.
• Excellent verbal and written communication skills.
• Ability to organize multiple work assignments and establish priorities.

Travel: up to 20% domestic and/or international business travel.

Equal Employment Opportunity.