Associate Director, Biostatistics
About The Position
The Associate Director of Biostatistics is a member of cross-functional Development teams and contributes to clinical trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, the role may support a particular indication of an asset and works collaboratively with the Biostatistics indication or asset Lead and other cross-functional team members. The role involves applying statistical and clinical-trial methodology throughout clinical development, contributing to study and project strategy, and producing clear, transparent analyses and study documentation. It also includes ensuring consistency, quality, and compliance with company processes and standards across multiple studies. The position contributes to the statistical community of practice and may include developing, coaching, and managing team members.
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, with experience in clinical trials, drug development, the pharmaceutical industry, or healthcare.
- Proficiency in scientific computing and programming using SAS, R, or Python, and in implementing 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 the ability to apply it to relevant clinical development frameworks.
- Good understanding of the regulatory landscape and experience participating in regulatory interactions.
- Ability to collaborate and demonstrate organizational, leadership, 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 on the design of innovative and efficient clinical trials, including selecting study populations and endpoints to address study objectives, and contribute to project development strategy.
- Defend protocols and analysis plans at internal governance reviews and independently review complex protocols.
- Independently author or review protocols, statistical analysis plans, clinical study reports, publications, and other study-level documents.
- Present summary data and analysis results clearly, concisely, completely, and transparently.
- Provide statistical support and leadership for health authority requests, publications, presentations, and other public releases of information.
- Manage multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area.
- Apply extensive knowledge of 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 external and internal statistical community of practice.
- Develop and advise team members.
- Communicate the DQS Mission and Vision in a way that generates pride, excitement, and commitment.
- 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.
- Flexible Time Off without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
- Paid company holidays: 11 annually for eligible employees.
- For specified non-exempt, RayzeBio, and Puerto Rico employees: 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
Senior
