Associate Director, Biostatistics
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Job Description
Associate Director leading statistical strategy and analysis for RayzeBio’s oncology radiopharmaceutical trials. Overseeing clinical trial outputs, vendors, regulatory submissions, and AI-enabled efficiency initiatives.
Responsibilities:
- Serve as the lead biostatistician for clinical oncology projects, developing and executing statistical strategies, study designs, and analyses.
- Collaborate with multidisciplinary project teams to ensure 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 key statistical documents and outputs, including protocol statistical sections, SAPs, and TLF shells.
- Review study-related documents and validate vendor deliverables, including CDISC data specifications and TLF/analysis outputs.
- Work with internal programmers to support regulatory requests, DSUR/IB updates, and ad-hoc analyses.
- Participate in internal sponsor review of ongoing clinical data.
- Explore and pilot AI initiatives that enhance quality control and operational efficiency.
- Travel approximately 10% of the time.
- Perform occasional evening and weekend work.
Requirements:
- Advanced degree in Statistics or Biostatistics (PhD or MS)
- 8+ years of biostatistics experience in the pharmaceutical/biotech industry with a PhD, or 10+ years with an MS
- Experience utilizing AI-enabled tools to improve productivity and work efficiency
- Familiarity with statistical programming tools such as SAS and/or R
- Working knowledge of CDISC standards (SDTM/ADaM)
- Ability to review and interpret key statistical outputs
- Ability to oversee vendors and ensure quality, timeliness, and compliance of biometrics deliverables
- Solid understanding of GCP, ICH guidelines, and regulatory requirements
- Excellent interpersonal and communication skills, with ability to influence cross-functional stakeholders
- Ability to function in a highly regulated environment and adhere to RayzeBio guidelines and SOPs
- Prior experience in oncology clinical development preferred
- Prior experience with global regulatory submissions preferred
- Willingness to travel approximately 10% of the time
- Availability for evening and weekend work
Benefits:
- Additional incentive cash and stock opportunities (based on eligibility)
- Medical, pharmacy, dental, and vision care
- BMS Well-Being Account
- BMS Living Life Better
- Employee Assistance Programs (EAP)
- 401(k) plan
- Short- and long-term disability
- Life insurance
- Accident insurance
- Supplemental health insurance
- Business travel protection
- Personal liability protection
- Identity theft benefit
- Legal support
- Survivor support
- Flexible time off (unlimited, with manager approval) for US Exempt Employees
- 11 paid national holidays for US Exempt Employees
- 160 hours annual paid vacation for Phoenix, AZ, Puerto Rico and RayzeBio Exempt, Non-Exempt, Hourly Employees
- 11 national holidays and 3 optional holidays for Phoenix, AZ, Puerto Rico and RayzeBio Exempt, Non-Exempt, Hourly Employees
- Unlimited paid sick time, based on eligibility
- Up to 2 paid volunteer days per year, based on eligibility
- Summer hours flexibility, based on eligibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Annual Global Shutdown between Christmas and New Years Day
- Reasonable workplace accommodations/adjustments and ongoing support
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