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:

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:

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 combines deep statistical expertise with strategic, hands‑on leadership across all phases of clinical development, from early‑phase dose finding and optimization through registrational trials and regulatory submissions.

• Serve as the lead biostatistician for clinical oncology projects, developing and executing statistical strategies, study designs, and analyses.
• Provide biostatistical support in interactions with global health authorities (e.g., FDA, EMA), including contributing to briefing documents, responses to agency questions, and submission dossiers.
• Partner 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, SAPs, and TLF shells.
• Review study‑related documents and review/validate vendor deliverables, including CDISC data specifications and TLF/analysis outputs.
• Partner with statistical programmers to support regulatory requests, DSUR/IB updates, publications, and ad‑hoc analyses as needed.
• Participate in the sponsor review of ongoing clinical data to ensure data integrity and identify emerging efficacy and safety trends.
• Explore, pilot, and help implement AI‑enabled tools and workflows that enhance quality control and operational efficiency.
• Willing to travel approximately 10% of the time. Occasional evening and weekend work may be required.

• 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.
• Proficiency in statistical software (e.g., SAS, R, EAST, including simulation for trial design) and working knowledge of CDISC standards (SDTM/ADaM), with the ability to review and interpret key statistical outputs.
• Demonstrated ability to oversee…