Associate Director, Biostatistics

Role Description

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.

Job 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.
• 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.

Qualifications

• 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.
• Applies AI to improve team execution and decision-making.

Requirements

• 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.

Preferred Requirements

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

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.

Compensation Overview

Remote - United States - US: $189,670 - $229,834. The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

• 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.
• Work-life benefits include flexible time off (unlimited, with manager approval), 11 paid national holidays, and additional time off for employees based on eligibility.