Sr Director, Biostatistics

Role: Senior Biostatistics Leader overseeing early-phase (1/2) clinical trials in oncology, focusing on statistical strategy, design, analysis, and biomarker integration. Responsibilities include managing biostatistics staff, developing departmental standards, providing strategic input on translational medicine and biomarkers, ensuring regulatory compliance, and overseeing CRO/vendor relationships. Requirements: MS/MA with 13+ years or PhD with 12+ years in biostatistics or related field, with extensive oncology trial management experience, particularly in phase 1/2 studies, and familiarity with biomarker/genomic data. Preferred skills include FDA/EMA/ICH guideline knowledge, CDISC standards, and experience interacting with regulatory agencies. High-value: oncology, early development stages, biomarker and translational science, regulatory and CRO oversight. Work setup: not specified but likely hybrid/office-based; extensive leadership and cross-functional collaboration.