Director, Biostatistics

Role: Lead biostatistics activities supporting clinical trials, with oversight of statistical programming, analysis, and reporting to ensure quality and regulatory compliance. Responsibilities: design and review protocols, statistical analysis plans, and datasets; validate complex data; prepare statistical reports and communicate findings; oversee CRO deliverables; contribute to regulatory submissions, especially NDA/BLA in oncology. Qualifications: Master's in statistics or biostatistics (PhD preferred); 7+ years in clinical trials with a focus on oncology; experience with phase 3 oncology trials, solid tumor indications, and global regulatory submissions; proficiency in SAS and R, with knowledge of additional analysis tools preferred. HighValue: oncology (solid tumor), phase 3, NDA/BLA, statistical programming, CRO oversight. WorkSetup: not specified, but likely collaborative with cross-functional teams; no travel explicitly stated.