Associate Director, Biostatistics

Associate Director, Biostatistics

Summary
- Guide the design, execution, and interpretation of statistical analyses for clinical trials to support development of innovative radiopharmaceutical therapies.

Job Responsibilities
- Serve as lead biostatistician for clinical oncology projects; develop and execute statistical strategies, study designs, and analyses.
- Collaborate with multidisciplinary teams to ensure timely communication and alignment.
- Identify and implement solutions for statistical and data analysis issues for clinical trials and regulatory submissions.
- Author/own key statistical documents and outputs (protocol statistical sections, SAPs, TLF shells).
- Review study documents; review/validate vendor deliverables (CDISC data specifications; TLF/analysis outputs).
- Work with internal programmers for regulatory requests, DSUR/IB updates, and ad-hoc analyses.
- Participate in internal sponsor review of ongoing clinical data.
- Explore and pilot AI initiatives to enhance quality control and operational efficiency.
- Travel ~10%; evening/weekend work involved.

Skills and Knowledge
- Strong interpersonal/communication skills to influence cross-functional stakeholders.
- Ability to work in a highly regulated environment and follow RayzeBio guidelines/SOPs.
- Familiarity with SAS and/or R; CDISC standards (SDTM/ADaM); ability to review/interpret statistical outputs.
- Experience overseeing vendors for quality, timeliness, and compliance of biometrics deliverables.
- Solid understanding of GCP, ICH guidelines, and regulatory requirements.
- Apply AI to improve execution and decision-making.

Basic Requirements
- PhD or MS in Statistics/Biostatistics.
- 6+ years (PhD) or 8+ years (MS) biostatistics experience in pharma/biotech.
- Experience using AI-enabled tools to improve productivity.

Preferred Requirements
- Prior oncology clinical development experience.
- Prior experience with global regulatory submissions.