Associate Director, Biostatistics
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Job Description
Associate Director leading clinical-trial biostatistics for RayzeBio, a Bristol Myers Squibb radiopharmaceutical biotech subsidiary. Guiding oncology analyses, regulatory submissions, and statistical strategy.
Responsibilities:
- Serve as lead biostatistician for clinical oncology projects
- Develop and execute statistical strategies, study designs, and analyses
- Provide biostatistical support for interactions with global health authorities, including FDA and EMA
- Contribute to briefing documents, agency-question responses, and submission dossiers
- Partner with multidisciplinary project teams to align objectives and ensure timely communication
- Identify and implement solutions to statistical and data-analysis issues for clinical trials and regulatory submissions
- Author and own protocol statistical sections, statistical analysis plans, and TLF shells
- Review study-related documents and validate vendor deliverables, including CDISC data specifications and TLF/analysis outputs
- Partner with statistical programmers on regulatory requests, DSUR/IB updates, publications, and ad hoc analyses
- Participate in sponsor review of ongoing clinical data to ensure integrity and identify efficacy and safety trends
- Explore, pilot, and help implement AI-enabled tools and workflows to improve quality control and operational efficiency
- Support development of radiopharmaceutical therapies through early-phase dose finding and optimization, registrational trials, and regulatory submissions
Requirements:
- Advanced degree in Statistics or Biostatistics (PhD or MS)
- 6+ years of biostatistics experience in the pharmaceutical/biotech industry for PhD holders, or 8+ years for MS holders
- Experience in oncology clinical development
- Experience applying Bayesian methods in a clinical development setting
- Proficiency in statistical software, including SAS, R, and EAST, including simulation for trial design
- Working knowledge of CDISC standards, including SDTM and ADaM
- Ability to review and interpret key statistical outputs
- 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
- Excellent interpersonal and communication skills
- Ability to function in a highly regulated environment and adhere to RayzeBio guidelines and SOPs
- Willingness to travel approximately 10% of the time
- Occasional evening and weekend work may be required
Benefits:
- Wellbeing support
- Retirement and financial protection benefits
- Medical, dental, vision, life and disability insurance offerings
- Flexible Time Off (FTO) for U.S.-based exempt employees
- 11 paid company holidays per year
- 160 hours of paid vacation annually for new hires for non-exempt employees, RayzeBio employees, and employees in Puerto Rico
- 3 optional holidays for non-exempt employees, RayzeBio employees, and employees in Puerto Rico
- Paid sick leave, subject to eligibility
- Up to two paid volunteer days per year
- Summer hours flexibility
- Medical, personal, parental, caregiver, bereavement, or military leaves of absence
- Annual Global Shutdown between Christmas Day and New Year's Day
- Reasonable workplace accommodations/adjustments and ongoing support for people with disabilities
- Additional discretionary incentive cash and stock opportunities may be available
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