Director, Biostatistics
Bristol Myers Squibb
15 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Position Summary
Director of Biostatistics (core member of cross-functional development team) leading statistical strategy for compounds within a therapeutic area; drives design of innovative/efficient clinical trials; develops trial designs for regulatory approval and market access; contributes to Clinical Development Plans, submissions, and post-submission strategies; provides guidance/oversight to statisticians; manages resources, priorities, and adherence to standards.
Key Responsibilities
- Drive study design supporting regulatory approval, medical research, and market access.
- Independently lead/initiate/oversee statistical support for compound development.
- Provide statistical guidance/oversight for high-quality, timely deliverables.
- Serve as matrix team scientific/strategic partner in drug development.
- Present/defend complex statistical solutions to governance, stakeholders, and regulators.
- Lead GBDS-related submission activities and post-submission strategies.
- Support health authority requests and external publication/presentation.
- Ensure compliance with BMS processes/SOPs and global/project standards.
- Contribute to creation/maintenance and training on statistical SOPs.
- Manage functional/project budget; allocate resources; set priorities.
- Represent BMS in societies/technical discussions; contribute to community of practice.
- Coach team members; communicate DQS mission/vision; foster inclusiveness/respect.
Applicable to People Managers
- Employee advocate and management coach/mentor; empower/develop team.
- Guide development plans; performance reviews/feedback; develop staff 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 in SAS, R, or Python; advanced statistical analysis, data manipulation, graphing & simulation.
- Excellent interpersonal, communication, writing, and organizational skills.
- Expertise in statistical/clinical trial methodology aligned to regulatory/industry standards.
- Experience with global regulatory agency interactions.
- Preferred: 3+ years direct or matrix management experience (people manager).
Benefits / Compensation (as stated)
- Starting pay range: $218,740–$265,060 (Madison–Giralda, NJ and Princeton, NJ).
- Health coverage; wellbeing support; 401(k) and protection benefits.
- Paid time off (flexible/unlimited for US exempt; 160 hours vacation for some; national holidays).
Note: No specific application instructions provided in the text.
Director of Biostatistics (core member of cross-functional development team) leading statistical strategy for compounds within a therapeutic area; drives design of innovative/efficient clinical trials; develops trial designs for regulatory approval and market access; contributes to Clinical Development Plans, submissions, and post-submission strategies; provides guidance/oversight to statisticians; manages resources, priorities, and adherence to standards.
Key Responsibilities
- Drive study design supporting regulatory approval, medical research, and market access.
- Independently lead/initiate/oversee statistical support for compound development.
- Provide statistical guidance/oversight for high-quality, timely deliverables.
- Serve as matrix team scientific/strategic partner in drug development.
- Present/defend complex statistical solutions to governance, stakeholders, and regulators.
- Lead GBDS-related submission activities and post-submission strategies.
- Support health authority requests and external publication/presentation.
- Ensure compliance with BMS processes/SOPs and global/project standards.
- Contribute to creation/maintenance and training on statistical SOPs.
- Manage functional/project budget; allocate resources; set priorities.
- Represent BMS in societies/technical discussions; contribute to community of practice.
- Coach team members; communicate DQS mission/vision; foster inclusiveness/respect.
Applicable to People Managers
- Employee advocate and management coach/mentor; empower/develop team.
- Guide development plans; performance reviews/feedback; develop staff 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 in SAS, R, or Python; advanced statistical analysis, data manipulation, graphing & simulation.
- Excellent interpersonal, communication, writing, and organizational skills.
- Expertise in statistical/clinical trial methodology aligned to regulatory/industry standards.
- Experience with global regulatory agency interactions.
- Preferred: 3+ years direct or matrix management experience (people manager).
Benefits / Compensation (as stated)
- Starting pay range: $218,740–$265,060 (Madison–Giralda, NJ and Princeton, NJ).
- Health coverage; wellbeing support; 401(k) and protection benefits.
- Paid time off (flexible/unlimited for US exempt; 160 hours vacation for some; national holidays).
Note: No specific application instructions provided in the text.