Associate Director, Biostatistics
About The Position
The Associate Director of Biostatistics serves on cross-functional Development teams and contributes to clinical trial design, protocol development, analysis planning, interpretation of results, and regulatory submissions. With appropriate experience, the role may support a particular asset indication. The Associate Director builds collaborative relationships and works effectively with the Biostatistics indication/asset Lead and other cross-functional partners. The position applies statistical and clinical-trial methodology to drug development, supports multiple studies within an indication or therapeutic area, and helps ensure consistency, quality, and adherence to applicable standards. It may include people-management responsibilities such as coaching and mentoring team members, supporting development plans and performance reviews, and developing staff performance metrics. Bristol Myers Squibb describes its work as focused on transforming patients’ lives through science across oncology, hematology, cell therapy, immunology, and cardiovascular disease. The role’s assigned work model is not specified in the posting.
Requirements
- PhD with at least 6 years of experience, or MS with at least 8 years of experience, in statistics, biostatistics, or a related scientific field.
- Experience in clinical trials, drug development, the pharmaceutical industry, or healthcare.
- Proficiency in scientific computing or programming using SAS, R, or Python.
- Ability to implement advanced statistical analyses, data manipulation, graphing, and simulation.
- Strong interpersonal, communication, writing, and organizational skills.
- Expertise in statistical and clinical-trial methodology as it relates to clinical development and ability to apply it within a relevant clinical development framework.
- Good understanding of the regulatory landscape and experience participating in regulatory interactions.
- Demonstrated collaboration, organizational and leadership abilities, and interpersonal skills.
- Ability to plan, organize, and prioritize multiple work assignments, with strong project-management skills.
Nice To Haves
- People-manager experience is preferred for people-manager positions.
Responsibilities
- Collaborate in designing innovative and efficient clinical trials, including selecting study populations and endpoints, and contribute to project development strategy.
- Defend protocols and analysis plans at internal governance reviews and independently review complex protocols.
- Author and/or review protocols, statistical analysis plans, clinical study reports, publications, and other study-level documents.
- Present summary data and analyses clearly, concisely, completely, and transparently.
- Provide statistical support and leadership for health authority requests, publications, presentations, and other public release of information.
- Manage multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area.
- Apply statistical and clinical-trial methodology to clinical development.
- Develop knowledge beyond traditional statistical expertise in clinical, regulatory, and commercial environments and apply it to study design.
- Engage effectively as a matrix-team member and scientific and strategic partner in drug development.
- Comply with BMS processes and SOPs, adhere to global and project standards, and ensure the quality of deliverables.
- Contribute to the internal and external statistical community of practice.
- Develop and advise team members.
- Communicate the DQS Mission and Vision in a way that generates pride, excitement, and commitment within DQS.
- For people-manager positions, act as an employee advocate and management coach or mentor; 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 offerings, subject to plan terms and eligibility.
- U.S.-based exempt employees are eligible for Flexible Time Off without a set accrual limit, subject to manager approval, and 11 paid company holidays annually.
- Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
- Depending on eligibility, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leave 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.
- Eligible employees may be offered discretionary incentive cash and stock opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
