Director, Biostatistics
Bristol Myers Squibb
5 days ago
Remote friendly (Madison, NJ)
United States
Clinical Research and Development
Position Summary
- Director of Biostatistics (core member of cross-functional development team) leads statistical strategy for compounds within a therapeutic area; drives innovative/efficient clinical trial design, trial design aligned to regulatory approval and market access, and contributes to clinical development plans, submissions, and post-submission strategies.
- Provides guidance/oversight to statisticians to ensure high-quality, timely deliverables; manages resources, sets priorities, and ensures adherence to standards.
Key Responsibilities
- Develops study designs addressing objectives for regulatory approval, medical research, and market access.
- Leads/initiates/oversees statistical support for compound development in a therapeutic area.
- Serves as matrix partner on development teams; presents/defends complex statistical solutions to governance, stakeholders, and regulators.
- Leads GBDS-related submissions activities; provides statistical support for health authority requests and public release (publications/presentations).
- Ensures compliance with BMS processes/SOPs and global/project standards; contributes to statistical SOPs and training.
- Manages functional/project budget and allocates resources; represents BMS in professional/technical discussions; contributes to community of practice.
- Coaches team members and fosters inclusive, respectful challenge.
Applicable to people managers
- Employee advocacy; management coaching/mentoring; leads/empowers and develops team; performance reviews/feedback; develops performance metrics.
Qualifications & Experience (required/preferred)
- PhD (9+ years) or MS (11+ years) in statistics/biostatistics or related field with clinical trials/drug development/pharma/healthcare experience.
- Proficiency: SAS or R or Python; advanced statistical analysis, data manipulation, graphing, simulation.
- Excellent communication/writing/organizational skills; expertise in statistical/clinical trial methodology aligned to regulatory/industry standards.
- Experience with global regulatory agency interactions.
- At least 3 years management (direct or matrix) preferred for people manager.
Compensation & Benefits (as stated)
- Madison/Giralda, NJ or Princeton, NJ: $218,740–$265,060 (plus possible incentive cash/stock).
- Benefits include health coverage; wellbeing support (incl. EAP); financial protection (401(k), disability, life/accident, etc.); paid time off (flexible time off for US exempt employees).
- Director of Biostatistics (core member of cross-functional development team) leads statistical strategy for compounds within a therapeutic area; drives innovative/efficient clinical trial design, trial design aligned to regulatory approval and market access, and contributes to clinical development plans, submissions, and post-submission strategies.
- Provides guidance/oversight to statisticians to ensure high-quality, timely deliverables; manages resources, sets priorities, and ensures adherence to standards.
Key Responsibilities
- Develops study designs addressing objectives for regulatory approval, medical research, and market access.
- Leads/initiates/oversees statistical support for compound development in a therapeutic area.
- Serves as matrix partner on development teams; presents/defends complex statistical solutions to governance, stakeholders, and regulators.
- Leads GBDS-related submissions activities; provides statistical support for health authority requests and public release (publications/presentations).
- Ensures compliance with BMS processes/SOPs and global/project standards; contributes to statistical SOPs and training.
- Manages functional/project budget and allocates resources; represents BMS in professional/technical discussions; contributes to community of practice.
- Coaches team members and fosters inclusive, respectful challenge.
Applicable to people managers
- Employee advocacy; management coaching/mentoring; leads/empowers and develops team; performance reviews/feedback; develops performance metrics.
Qualifications & Experience (required/preferred)
- PhD (9+ years) or MS (11+ years) in statistics/biostatistics or related field with clinical trials/drug development/pharma/healthcare experience.
- Proficiency: SAS or R or Python; advanced statistical analysis, data manipulation, graphing, simulation.
- Excellent communication/writing/organizational skills; expertise in statistical/clinical trial methodology aligned to regulatory/industry standards.
- Experience with global regulatory agency interactions.
- At least 3 years management (direct or matrix) preferred for people manager.
Compensation & Benefits (as stated)
- Madison/Giralda, NJ or Princeton, NJ: $218,740–$265,060 (plus possible incentive cash/stock).
- Benefits include health coverage; wellbeing support (incl. EAP); financial protection (401(k), disability, life/accident, etc.); paid time off (flexible time off for US exempt employees).