Senior Director, Biostatistics
Bristol Myers Squibb
1 month ago
Remote friendly (Cambridge Crossing, FL)
United States
Clinical Research and Development
Role: Senior Director, Biostatistics (DQS Lead)
Responsibilities / Accountabilities
- Leads biostatistics and serves as DQS Lead for the global program team, translating complex data into decision-shaping insights for program strategy, governance, and regulatory decisions.
- Provides statistical input to development strategies and implementation plans for product development and/or market access objectives in a global organization.
- Provides expertise and guidance with cross-functional teams on study design, analysis strategy, and best practices across planning, execution, interpretation, and regulatory submission of clinical projects and studies.
- Guides and manages statisticians to ensure high-quality, timely deliverables.
- Manages resources, sets priorities, ensures consistency and adherence to standards.
- Through matrix leadership across DQS functions, ensures fit-for-purpose execution, proactively manages risk, and partners with cross-functional leaders to drive defensible decisions that accelerate delivery of medicines to patients.
- Leads and develops teams in a matrixed global environment; sets priorities and allocates resources to protect portfolio milestones; partners cross-functionally to ensure compliant, scalable execution and an inclusive culture.
Key Responsibilities
- Develops and reviews statistical analysis plans aligned with study objectives and regulatory requirements.
- Provides expert statistical guidance into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications.
- Provides statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions, and follow-up.
- Manages relationships with external partners and vendors to ensure quality and timeliness of statistical deliverables.
- Leads development and adaptation of new statistical methodologies, staying current with regulatory guidance.
- Leads and oversees the biostatistics team to deliver statistical analysis plans and reports for clinical trials.
People Management Accountabilities
- Provides leadership and direction through multiple levels of managers and/or expert-level individual contributors across departments.
- Directly accountable for performance/results of a large department, region/key market, or complex/multiple sites.
- Develops function strategy and contributes to broader organization strategy.
Compensation & Benefits (as stated)
- Princeton, NJ: $249,480–$302,305 (starting range).
- Health Coverage (medical, pharmacy, dental, vision); Wellbeing programs; Financial well-being/protection (401(k), disability, life insurance, etc.); Paid Time Off (flexible time off/vacation options depending on location/role), plus additional time-off and Global Shutdown (eligibility-based).
Application Instructions
- If the role doesn’t perfectly align with your resume, you are encouraged to apply anyway.
Responsibilities / Accountabilities
- Leads biostatistics and serves as DQS Lead for the global program team, translating complex data into decision-shaping insights for program strategy, governance, and regulatory decisions.
- Provides statistical input to development strategies and implementation plans for product development and/or market access objectives in a global organization.
- Provides expertise and guidance with cross-functional teams on study design, analysis strategy, and best practices across planning, execution, interpretation, and regulatory submission of clinical projects and studies.
- Guides and manages statisticians to ensure high-quality, timely deliverables.
- Manages resources, sets priorities, ensures consistency and adherence to standards.
- Through matrix leadership across DQS functions, ensures fit-for-purpose execution, proactively manages risk, and partners with cross-functional leaders to drive defensible decisions that accelerate delivery of medicines to patients.
- Leads and develops teams in a matrixed global environment; sets priorities and allocates resources to protect portfolio milestones; partners cross-functionally to ensure compliant, scalable execution and an inclusive culture.
Key Responsibilities
- Develops and reviews statistical analysis plans aligned with study objectives and regulatory requirements.
- Provides expert statistical guidance into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications.
- Provides statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions, and follow-up.
- Manages relationships with external partners and vendors to ensure quality and timeliness of statistical deliverables.
- Leads development and adaptation of new statistical methodologies, staying current with regulatory guidance.
- Leads and oversees the biostatistics team to deliver statistical analysis plans and reports for clinical trials.
People Management Accountabilities
- Provides leadership and direction through multiple levels of managers and/or expert-level individual contributors across departments.
- Directly accountable for performance/results of a large department, region/key market, or complex/multiple sites.
- Develops function strategy and contributes to broader organization strategy.
Compensation & Benefits (as stated)
- Princeton, NJ: $249,480–$302,305 (starting range).
- Health Coverage (medical, pharmacy, dental, vision); Wellbeing programs; Financial well-being/protection (401(k), disability, life insurance, etc.); Paid Time Off (flexible time off/vacation options depending on location/role), plus additional time-off and Global Shutdown (eligibility-based).
Application Instructions
- If the role doesn’t perfectly align with your resume, you are encouraged to apply anyway.