Vice President, Biostatistics

Role: Senior Biostatistics leader responsible for developing and overseeing biostatistics strategies, processes, and personnel to ensure high-quality, efficient clinical trial data analysis. Primary objectives include aligning statistical activities with drug development strategies, maintaining regulatory compliance, and optimizing data integrity across phases I–IV trials, with a focus on oncology therapeutics. Responsibilities encompass leading cross-functional collaborations, managing vendor relationships (CROs, academic partners), overseeing regulatory interactions (FDA/EU), and establishing best practices for biostatistics operations, tools, and methodologies. The role also involves strategic input on Real World Data analyses, budgeting, and supervising senior staff. Requirements include a PhD in a related field with at least 17 years of industry experience, including 8+ years in functional management roles within oncology clinical trials supporting US NDA filings. Proven expertise in clinical trial design, regulatory engagement, and leadership in biostatistics is essential. Preferred qualifications include extensive experience in oncology biostatistics, successful management of Phase I–III studies, and familiarity with FDA/EU regulations. High-value biopharma specifics involve leadership in oncology drug development, regulatory strategy, and cross-functional stakeholder engagement. The position supervises employees directly and indirectly, reports to executive leadership, and is based in a modern office environment with hybrid work options, though travel specifics are not detailed.