Associate Director, Biostatistics
Core
Lead biostatistician guiding the 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, and regulatory submission dossiers for oncology radiopharmaceuticals
Domain
Oncology clinical development / Radiopharmaceuticals
Required skills
SAS, R, EAST, CDISC standards (SDTM/ADaM), Bayesian methods, GCP, ICH guidelines, oncology trial design, vendor oversight
Preferred skills
Radiopharmaceutical therapy (RPT) or imaging (RPI) drug development, global regulatory submissions, innovative clinical trial designs (adaptive), AI-enabled tools
Technologies
SAS, R, EAST
Responsibilities
Develop and execute statistical strategies and study designs; Author protocol statistical sections, SAPs, and TLF shells; Review and validate vendor deliverables; Partner with programmers for regulatory requests and publications; Participate in sponsor review of clinical data; Interact with global health authorities (FDA, EMA)
Seniority
Senior, hands-on IC