Executive Director, Biostatistics

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RayzeBio is seeking an experienced and visionary Executive Director of Biostatistics to lead theranostic (imaging and therapeutic) development within the Biometrics department. This position requires not only deep expertise in biostatistical methodologies but also the ability to provide strategic vision, regulatory leadership, and cross-functional influence throughout the drug development process. The Executive Director will mentor and grow the internal statistics team, strengthen statistical processes and SOPs, and ensure RayzeBio remains submission and inspection ready as its pipeline expands.

This role also carries expanded organizational accountability to drive the thoughtful adoption and integration of AI and machine learning innovations across the Biometrics function, enabling more efficient, rigorous, and forward-looking clinical development at RayzeBio.

Job Responsibilities:

Essential duties and responsibilities include the following. Other duties may be assigned.

• Lead end-to-end statistical strategy for clinical programs from early-phase through NDA/MAA submissions and product launch.

• Provide statistical leadership for regulatory interactions, including FDA/EMA meetings, Advisory Committees, inspection readiness, and submission deliverables.

• Design and implement innovative trial methodologies to accelerate clinical development while ensuring statistical rigor and regulatory alignment.

• Collaborate with cross-functional teams to drive development decisions and integrate statistical perspectives into program strategies.

• Oversee biostatistics deliverables, including protocol development, SAPs, TFLs, and CSRs, ensuring accuracy, quality, and timely completion.

• Partner with internal programming and data management teams to support regulatory requests, publications, safety updates, and exploratory analyses.

• Participate in and lead internal sponsor reviews of ongoing trial data, providing clear statistical insights for decision-making.

• Oversee resource allocation and budget planning for biostatistics activities across assigned programs.

• Build and mentor a high-performing project team, provide coaching and career development to direct reports.

• Develop and establish SOPs and best practices within biostatistics and programming.

• Serve as the Biometrics lead for AI-related initiatives, partnering with internal stakeholders and external vendors to explore and pilot AI solutions that support quality control and operational efficiency.

• Streamline and standardize Biometrics processes to enable consistent and compliant implementation of approved AI tools.

• Willing to travel approximately 10% of the time.  Evening and weekend work will be involved.

• Utilize AI as a lever for scientific, operational, and commercial advantage.

Requirements:

• Advanced degree in Statistics or Biostatistics

• 15+ years of biostatistics experience in pharmaceutical/biotech industry.

• Solid understanding of GCP, ICH guidelines, and regulatory requirements.

• Prior oncology experience

• Proven track record of leadership, mentoring, and team development.

• Ability to balance strategic leadership with hands-on execution of statistical analyses and deliverables.

• 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 standard operating procedures (SOPs).

Preferr