Director Biostatistics
Bristol Myers Squibb
6 months ago
Remote friendly (Madison, NJ)
United States
Clinical Research and Development
Position Summary
- Director of Biostatistics is a member of a cross-functional team and contributes to development of compounds within a therapeutic area.
- Drives the design of innovative and efficient clinical trials, including selection of populations and endpoints.
- Develops trial designs to support regulatory approval and market access.
- Contributes to Clinical Development Plans, submissions, and post-submission strategies, preparations, and defenses.
- Provides guidance and management to statisticians to ensure high quality and timely deliverables.
- Manages resources, sets priorities, and ensures consistency and adherence to standards.
Key Responsibilities
- Drives innovative and efficient study design to address study objectives supporting regulatory approval, medical research, and market access.
- Independently leads, initiates, and oversees statistical support for development of compounds within a therapeutic area.
- Provides guidance and management to statisticians for high quality and timely deliverables.
- Engages as a matrix team member on high-level development teams as a scientific and strategic partner.
- Presents and defends complex statistical solutions to BMS governance, stakeholders, and external regulatory bodies.
- Contributes to Clinical Development Plans; leads GBDS-related submission activities and post-submission strategies/preparations/defenses.
- Provides statistical support and leadership for health authority requests, publications, presentations, and other public releases.
- Complies with BMS processes and SOPs; adheres to global/project standards; ensures deliverable quality.
- Contributes to creation/maintenance of statistical departmental SOPs and provides training.
- Manages functional/project budgets and allocates resources according to project needs; sets priorities and ensures adherence to standards.
- Represents BMS at professional societies and in industry-wide technical discussions.
- Contributes to the statistical community of practice.
- Provides active coaching to biostatistical team members when developing solutions.
- Communicates the GBDS Mission and Vision and enables a culture of inclusiveness, respect for diversity, and respectful challenge.
People Manager (Applicable)
- Acts as an employee advocate and management coach/mentor internally and externally.
- Provides leadership to empower and develop the team.
- Guides employee development plans; conducts performance review/feedback; develops staff performance metrics.
Qualifications & Experience
- PhD (9+ years) or MS (11+ years) in statistics, biostatistics, or related scientific field with clinical trials/drug development/pharmaceutical industry/healthcare experience.
- Proficiency in scientific computing/programming (SAS, R, or Python) and advanced statistical analysis implementation (data manipulation, graphing, simulation).
- Excellent interpersonal, communication, writing, and organizational skills.
- Expertise applying general and cutting-edge statistical/clinical trials methodology to solve complex clinical development statistical problems and align with regulatory and industry standards.
- Experience preparing and participating in global regulatory agency interactions.
- Strong collaboration, organizational, and leadership abilities.
- Demonstrated development of approaches to enhance Workforce Planning and Talent Management strategy for internal/external talent pools within a therapeutic area.
- Preferred: at least 3 years management (direct or matrix) experience (for people manager positions).
Compensation (if applicable)
- Madison/Giralda, NJ, US: $218,740–$265,060 (full-time FTE). Additional incentive cash and stock opportunities may be available (based on eligibility).
Benefits (explicitly stated)
- Health Coverage: medical, pharmacy, dental, vision.
- Wellbeing Support: BMS Well-Being Account, BMS Living Life Better, EAP.
- Financial Well-being and Protection: 401(k), short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, survivor support.
- Paid Time Off: flexible time off (unlimited with manager approval) for US exempt employees; 11 paid national holidays (with noted exceptions). Other roles: 160 hours annual paid vacation (with manager approval) and 11 national holidays plus 3 optional holidays.
- Additional time off may include unlimited paid sick time, up to 2 paid volunteer days/year, summer hours flexibility, leaves of absence, and an annual Global Shutdown between Christmas and New Year’s Day (eligibility-based).
Application Instructions
- Apply for the role even if your resume does not perfectly align with the requirements.
- Director of Biostatistics is a member of a cross-functional team and contributes to development of compounds within a therapeutic area.
- Drives the design of innovative and efficient clinical trials, including selection of populations and endpoints.
- Develops trial designs to support regulatory approval and market access.
- Contributes to Clinical Development Plans, submissions, and post-submission strategies, preparations, and defenses.
- Provides guidance and management to statisticians to ensure high quality and timely deliverables.
- Manages resources, sets priorities, and ensures consistency and adherence to standards.
Key Responsibilities
- Drives innovative and efficient study design to address study objectives supporting regulatory approval, medical research, and market access.
- Independently leads, initiates, and oversees statistical support for development of compounds within a therapeutic area.
- Provides guidance and management to statisticians for high quality and timely deliverables.
- Engages as a matrix team member on high-level development teams as a scientific and strategic partner.
- Presents and defends complex statistical solutions to BMS governance, stakeholders, and external regulatory bodies.
- Contributes to Clinical Development Plans; leads GBDS-related submission activities and post-submission strategies/preparations/defenses.
- Provides statistical support and leadership for health authority requests, publications, presentations, and other public releases.
- Complies with BMS processes and SOPs; adheres to global/project standards; ensures deliverable quality.
- Contributes to creation/maintenance of statistical departmental SOPs and provides training.
- Manages functional/project budgets and allocates resources according to project needs; sets priorities and ensures adherence to standards.
- Represents BMS at professional societies and in industry-wide technical discussions.
- Contributes to the statistical community of practice.
- Provides active coaching to biostatistical team members when developing solutions.
- Communicates the GBDS Mission and Vision and enables a culture of inclusiveness, respect for diversity, and respectful challenge.
People Manager (Applicable)
- Acts as an employee advocate and management coach/mentor internally and externally.
- Provides leadership to empower and develop the team.
- Guides employee development plans; conducts performance review/feedback; develops staff performance metrics.
Qualifications & Experience
- PhD (9+ years) or MS (11+ years) in statistics, biostatistics, or related scientific field with clinical trials/drug development/pharmaceutical industry/healthcare experience.
- Proficiency in scientific computing/programming (SAS, R, or Python) and advanced statistical analysis implementation (data manipulation, graphing, simulation).
- Excellent interpersonal, communication, writing, and organizational skills.
- Expertise applying general and cutting-edge statistical/clinical trials methodology to solve complex clinical development statistical problems and align with regulatory and industry standards.
- Experience preparing and participating in global regulatory agency interactions.
- Strong collaboration, organizational, and leadership abilities.
- Demonstrated development of approaches to enhance Workforce Planning and Talent Management strategy for internal/external talent pools within a therapeutic area.
- Preferred: at least 3 years management (direct or matrix) experience (for people manager positions).
Compensation (if applicable)
- Madison/Giralda, NJ, US: $218,740–$265,060 (full-time FTE). Additional incentive cash and stock opportunities may be available (based on eligibility).
Benefits (explicitly stated)
- Health Coverage: medical, pharmacy, dental, vision.
- Wellbeing Support: BMS Well-Being Account, BMS Living Life Better, EAP.
- Financial Well-being and Protection: 401(k), short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, survivor support.
- Paid Time Off: flexible time off (unlimited with manager approval) for US exempt employees; 11 paid national holidays (with noted exceptions). Other roles: 160 hours annual paid vacation (with manager approval) and 11 national holidays plus 3 optional holidays.
- Additional time off may include unlimited paid sick time, up to 2 paid volunteer days/year, summer hours flexibility, leaves of absence, and an annual Global Shutdown between Christmas and New Year’s Day (eligibility-based).
Application Instructions
- Apply for the role even if your resume does not perfectly align with the requirements.