Director, Biostatistics
About The Position
The Director of Biostatistics is a member of cross-functional teams and contributes to compound development within a therapeutic area. The role drives the design of innovative and efficient clinical trials, including selecting study populations and endpoints. It develops trial designs that address study objectives and support regulatory approval, medical research, and market access. The Director independently leads and oversees statistical support for compound development, contributes to Clinical Development Plans and submission activities, and supports post-submission strategies, preparations, and defenses. The role presents and defends complex statistical solutions to internal governance, stakeholders, and external regulatory bodies. It provides leadership, guidance, and management to statisticians; manages resources and priorities; and ensures high-quality, timely deliverables that comply with company processes, SOPs, and applicable standards. The position also contributes to statistical procedures and training, supports health authority requests and public communications, represents BMS at professional societies and industry discussions, and coaches and develops team members, including supporting development plans and performance reviews.
Requirements
- PhD with 9 or more years of experience, or MS with 11 or more years of experience, in statistics, biostatistics, or a related scientific field, with experience in clinical trials, drug development, the pharmaceutical industry, or healthcare.
- Proficiency in scientific computing and programming with SAS, R, or Python, including advanced statistical analysis, data manipulation, graphing, and simulation.
- Excellent interpersonal, communication, writing, and organizational skills.
- Expertise applying general and cutting-edge statistical and clinical-trial methodologies to complex clinical-development problems, aligned with regulatory agencies and industry standards.
- Experience preparing for and participating in global regulatory agency interactions.
- Excellent collaboration, organizational, leadership, and interpersonal abilities.
- Ability to develop approaches that enhance workforce planning and talent management for internal and external talent pools within a therapeutic area.
Nice To Haves
- At least 3 years of direct or matrix management experience (preferred for people manager positions).
Responsibilities
- Drive innovative and efficient study design, developing designs that address study objectives and support regulatory approval, medical research, and market access.
- Independently lead, initiate, and oversee statistical support for compound development within a therapeutic area.
- Provide guidance and management to statisticians to ensure high-quality, timely deliverables.
- Engage as a scientific and strategic partner on high-level cross-functional development teams.
- Present and defend complex statistical solutions to BMS governance, stakeholders, and external regulatory bodies.
- Contribute to Clinical Development Plans, lead GBDS-related submission activities, and support post-submission strategies, preparations, and defenses.
- Provide statistical support and leadership for health authority requests, publications, presentations, and other public releases of information.
- Ensure compliance with BMS processes and SOPs, global and project standards, and quality expectations for deliverables.
- Contribute to the creation and maintenance of departmental statistical SOPs and provide training on statistical topics.
- Manage a functional or project budget, allocate company resources according to project needs, set priorities, and ensure consistency and adherence to standards.
- Represent BMS at professional societies and industry-wide technical discussions.
- Contribute to the statistical community of practice.
- Coach biostatistical team members as they develop solutions to problems.
- Communicate the GBDS mission and vision to foster pride, excitement, and commitment within GBDS.
- Act as an employee advocate and management coach or mentor to team members internally and externally.
- Provide leadership to empower and develop the team.
- Guide employee development plans, conduct performance reviews and provide feedback, and develop staff performance metrics.
Benefits
- Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance.
- Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
- Eleven paid company holidays each year.
- For specified employee groups, 160 hours of paid vacation annually for new hires, subject to manager approval, and 3 optional holidays.
- Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
- Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
- Potential eligibility for discretionary incentive cash and stock opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Director
