Associate Director, Biostatistics

Bristol Myers Squibb•San Diego, CA

23h•Onsite

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.
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.
Experience with innovative/novel clinical trial designs (e.g., adaptive designs).
Experience applying Bayesian methods in a clinical development setting.

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.
Partner with the Biometrics AI lead and internal/external stakeholders to explore and pilot AI initiatives that enhance quality control and operational efficiency.

Benefits

Medical, pharmacy, dental, and vision care.
Programs such as BMS Well-Being Account, BMS Living Life Better, and 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, and survivor support.
Flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)) for US Exempt Employees.
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees.
Unlimited paid sick time.
Up to 2 paid volunteer days per year.
Summer hours flexibility.
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
Annual Global Shutdown between Christmas and New Years Day.