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:

Rayze Bio is a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. Rayze Bio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, Rayze Bio aims to be the global leader in radiopharmaceuticals

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/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.

• 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 Rayze Bio 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).
• 8+ years (PhD) or 10+ years (MS) of biostatistics experience in the pharmaceutical/biotech industry.
• Experience utilizing AI-enabled tools to improve productivity and work efficiency.

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

• While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.

• The noise level in the work environment is usually moderate.

Remote - United States - US: $189,670 - $229,834

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