Senior Principal Statistician

Role: Senior Principal Statistician leading statistical design, analysis, and reporting for clinical trials from Phase I to IV in oncology and neuroscience therapeutics. Responsibilities: develop and validate statistical analysis plans, collaborate across functions (clinical development, regulatory, data management), manage external vendors, prepare for regulatory interactions, and contribute to integrated summaries and regulatory submissions. Requirements: MS or MPH in statistics or related field with over 4 years (PhD with 2+) industry experience; expertise in trial design, statistical modeling, hypothesis testing, and sample size calculations; proficiency in SAS and R; knowledge of ICH guidelines, CDISC standards, and drug development regulations. Preferred: experience with Bayesian/adaptive designs, oncology/hematology indications, and regulatory filings. High-value: involvement in biopharma clinical research, with a focus on oncology or neuroscience, supporting regulatory submissions, and working on early to late-stage trials. Cross-functional collaboration with development, regulatory, and programming teams. Work setup: not explicitly specified, but role involves interaction with external vendors and regulatory bodies, implying a primarily office-based or hybrid environment.