Associate Director, Biostatistics

At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly‑owned subsidiary of Bristol Myers Squibb, Rayze Bio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you'll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do.

From day one, expect to make an immediate impact on our science, on our teams, and most importantly, on patients. Learn more about Rayze Bio:

Job Title: Associate Director, Biostatistics

Department: Biometrics

Location: San Diego

FLSA Status: Exempt

Reports to: Executive Director, Biostatistics

The Associate Director of Biostatistics at Rayze Bio 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.

• 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 and own key statistical documents and outputs, including protocol statistical sections, statistical analysis plans (SAP), and TLF shells.
• Review study‑related documents and 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.

• Willingness to travel approximately 10% of the time; evening and weekend work may be required.
• Excellent interpersonal and communication skills, with the ability to influence cross‑functional stakeholders.
• Ability to function in a highly regulated environment and adhere to all Rayze Bio guidelines and SOPs.
• Familiarity with statistical programming tools such as SAS and/or R and working knowledge of CDISC standards (SDTM/ADaM); 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 of biostatistics experience in the pharmaceutical/biotech industry (PhD) or 8+ years (MS).
• Experience utilizing AI‑enabled tools to improve productivity and work efficiency.
• 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.

San Diego - Rayze Bio - CA: $190,539 - $230,888

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental and vision care.
• Wellbeing Support: Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well‑being and Protection: 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.
• Paid…