Associate Director, Biostatistics
Core
Lead biostatistician guiding design, execution, and interpretation of statistical analyses for oncology clinical trials to develop radiopharmaceutical therapies.
Role type
Senior IC biostatistician (Associate Director)
Builds
Clinical trial statistical strategies, study designs, analyses, and regulatory submission dossiers for oncology radiopharmaceuticals.
Domain
Oncology clinical development / Radiopharmaceutical therapy
Required skills
Biostatistics, SAS, R, CDISC standards (SDTM/ADaM), Bayesian methods, Oncology clinical development, Regulatory submissions (FDA/EMA), Vendor oversight, GCP/ICH guidelines
Preferred skills
Radiopharmaceutical therapy (RPT) or imaging (RPI) drug development, Innovative clinical trial designs (adaptive), AI-enabled tools
Technologies
SAS, R, EAST
Responsibilities
Develop and execute statistical strategies and study designs for clinical oncology projects; Author and own key statistical documents (protocol sections, SAPs, TLF shells); Provide biostatistical support in interactions with global health authorities; Review study-related documents and validate vendor deliverables; Partner with statistical programmers for regulatory requests and publications; Participate in sponsor review of ongoing clinical data; Explore and pilot AI-enabled tools for quality control and efficiency.
Seniority
Senior, hands-on IC with strategic leadership