Senior Biostatistics Director

Role: Senior Biostatistician providing strategic leadership within biostatistics for clinical trial design, analysis, and regulatory interactions across all phases. Responsibilities: develop and execute statistical strategies, review protocols and analysis plans, interpret results, and ensure compliance with FDA/EU guidelines; collaborate with clinical teams, oversee vendor management, and contribute to regulatory submissions. Qualifications: PhD in Statistics/Biostatistics with 12+ years relevant industry experience, preferably in oncology; extensive knowledge of clinical trial designs, CDISC standards, and statistical software (SAS, EAST, nQuery). HighValue: leadership in biotech/pharma, oncology therapeutic area, extensive Phase I-IV trial experience supporting NDAs, direct FDA/EU interaction, and management of complex data analyses. WorkSetup: not specified, but likely office-based with cross-functional collaboration.