Associate Director, Biostatistics

Bristol Myers Squibb
•$189,670 - $229,834•Remote

About The Position

The Associate Director of Biostatistics at RayzeBio will play a crucial role in guiding the design, execution, and interpretation of statistical analyses for clinical trials, with the overarching goal of facilitating the successful development of innovative radiopharmaceutical therapies. This position requires not only a deep understanding of biostatistical methodologies but also the ability to provide strategic guidance and expert insights throughout the drug development process.

Requirements

  • Excellent interpersonal and communication skills, with the ability to influence cross-functional stakeholders.
  • Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and SOPs.
  • Familiarity with statistical programming tools (e.g., SAS and/or R) and working knowledge of CDISC standards (SDTM/ADaM), with the ability to review and interpret key statistical outputs.
  • Demonstrated ability to oversee vendors and ensure the quality, timeliness, and compliance of biometrics deliverables.
  • Solid understanding of GCP, ICH guidelines, and regulatory requirements.
  • Applies AI to improve team execution and decision‑making
  • Advanced degree in Statistics or Biostatistics (PhD or MS).
  • 6+ years (PhD) or 8+ years (MS) of biostatistics experience in the pharmaceutical/biotech industry.
  • Experience utilizing AI-enabled tools to improve productivity and work efficiency.

Nice To Haves

  • Prior experience in oncology clinical development.
  • Prior experience with global regulatory submissions.

Responsibilities

  • Serve as the lead biostatistician for clinical oncology projects, developing and executing statistical strategies, study designs, and analyses.
  • Collaborate closely 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/own key statistical documents and outputs, including protocol statistical sections, SAPs, and TLF shells.
  • Review study-related documents and review/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 as needed.
  • Participate in the internal sponsor review of ongoing clinical data.
  • Explore and pilot AI initiatives that enhance quality control and operational efficiency.
  • Willing to travel approximately 10% of the time.
  • Evening and weekend work will be involved.

Benefits

  • wellbeing support
  • retirement and financial protection benefits
  • insurance offerings (medical, dental, vision, life and disability)
  • Flexible Time Off (FTO)
  • 11 paid company holidays each year
  • 160 hours of paid vacation annually for new hires
  • 3 optional holidays
  • paid sick leave
  • up to two paid volunteer days per year
  • summer hours flexibility
  • leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
  • annual Global Shutdown between Christmas Day and New Year's Day
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