Director, Biostatistics

Role: Senior Biostatistician leading statistical analysis for multiple research programs at a biopharma focused on cardiovascular and inflammatory diseases. Responsibilities: provide strategic statistical guidance, develop and review clinical development plans, study protocols, analysis plans, and regulatory submissions; oversee database development, analysis, and reporting standards; coordinate with Data Management and Programming teams; ensure quality vendor deliverables; support publications and regulatory interactions. Qualifications: PhD in biostatistics or statistics with at least 8 years' pharma/biotech experience; expert knowledge of clinical trial design, statistical methods, and regulatory requirements (FDA, ICH); strong SAS and R programming skills; experience with IND, NDA, MAA submissions preferred; excellent communication, project management, and cross-functional collaboration skills. High-Value: leadership in statistical aspects of clinical development, regulatory submission experience, focus on cardiovascular and inflammation indications, GxP compliance, role reporting to Biometrics Head, hybrid/onsite work setup.