Associate Director, Biostatistics

Life at BMS

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio 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 RayzeBio: https://careers.bms.com/rayzebio/

Summary

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 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.

Job Responsibilities

• 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.

Skills and Knowledge

• 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.
• 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 vendors and ensure the quality, timeliness, and compliance of biometrics deliverables.
• Solid understanding of GCP, ICH guidelines, and global regulatory requirements.
• In-depth knowledge of statistical methods for oncology trials.

Basic 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 in oncology clinical development
• Experience applying Bayesian methods in a clinical development setting

Preferred Requirements

• Prior experience in radiopharmaceutical therapy (RPT) or imaging (RPI) drug development
• Prior experience with global regulatory submissions
• Prior experience with innovative clinical trial designs (e.g., adaptive designs)
• Prior experience utilizing AI-enabled tools to improve productivity and work efficiency

Physical demands

• 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.

Work Environment

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

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Remote - United States - US: $173,217 - $209,899


The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. …