Associate Director, Biostatistics

Bristol Myers Squibb

2d • $173,217 - $209,899 • Remote

About The Position

The Associate Director of Biostatistics at RayzeBio provides strategic and hands-on statistical leadership for clinical oncology projects, guiding the design, execution, and interpretation of analyses across clinical development. The work spans early-phase dose finding and optimization through registrational trials and regulatory submissions, supporting the development of radiopharmaceutical therapies.

The role leads statistical strategy, study design, and analysis; supports interactions with global health authorities; authors and owns statistical documents and outputs; and collaborates with multidisciplinary teams, statistical programmers, and vendors. It also includes reviewing ongoing clinical data for integrity and emerging efficacy and safety trends, and piloting AI-enabled tools and workflows to improve quality control and operational efficiency. Travel is approximately 10%, and occasional evening or weekend work may be required.

Requirements

• Advanced degree in Statistics or Biostatistics (PhD or MS).
• At least 6 years of biostatistics experience in the pharmaceutical or biotech industry with a PhD, or at least 8 years with an MS.
• Experience in oncology clinical development.
• Experience applying Bayesian methods in a clinical development setting.
• Excellent interpersonal and communication skills, with the ability to influence cross-functional stakeholders.
• Ability to work in a highly regulated environment and adhere to RayzeBio guidelines and standard operating procedures.
• Proficiency in statistical software such as SAS, R, and EAST, including simulation for trial design.
• Working knowledge of CDISC standards (SDTM/ADaM) and ability to review and interpret statistical outputs.
• Demonstrated ability to oversee vendors and ensure the quality, timeliness, and compliance of biometrics deliverables.
• Solid understanding of GCP, ICH guidelines, and global regulatory requirements.
• In-depth knowledge of statistical methods for oncology trials.

Nice To Haves

• Prior experience in radiopharmaceutical therapy (RPT) or imaging (RPI) drug development.
• Prior experience with global regulatory submissions.
• Prior experience with innovative clinical trial designs, such as adaptive designs.
• Prior experience using AI-enabled tools to improve productivity and work efficiency.

Responsibilities

• Serve as lead biostatistician for clinical oncology projects, developing and executing statistical strategies, study designs, and analyses.
• Provide biostatistical support for interactions with global health authorities, including briefing documents, agency-question responses, and submission dossiers.
• Partner with multidisciplinary project teams to support timely communication and alignment of objectives.
• Identify and implement solutions to statistical and data-analysis issues related to clinical trials and regulatory submissions.
• Author and own statistical documents and outputs, including protocol statistical sections, statistical analysis plans (SAPs), and tables, listings, and figures (TLF) shells.
• Review study-related documents and validate vendor deliverables, including CDISC data specifications and TLF and analysis outputs.
• Partner with statistical programmers on regulatory requests, DSUR and IB updates, publications, and ad-hoc analyses.
• Participate in sponsor review of ongoing clinical data to support data integrity and identify emerging efficacy and safety trends.
• Explore, pilot, and help implement AI-enabled tools and workflows that enhance quality control and operational efficiency.
• Travel approximately 10%; occasional evening and weekend work may be required.

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.
• Flexible Time Off for eligible U.S.-based exempt employees, with no set accrual limit and subject to manager approval.
• 11 paid company holidays each year.
• For eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico: 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 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.
• May be eligible for additional discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior