Head of Biostatistics

Head of BiostatisticsAbout the CompanyAccomplished biopharmaceutical companyIndustry BiotechnologyType Privately HeldAbout the RoleThe Company is seeking a Head of Biostatistics to provide strategic and operational leadership to the statistical team. The successful candidate will be responsible for the oversight of biostatisticians, consultants, and programmers, both internally and from external vendors. This role involves direct collaboration with clinical development, regulatory, and quality teams in various aspects, including audit readiness, process development, and reporting. The Head of Biostatistics will also play a key role in the development of clinical study designs, data analysis, interpretation, and contribute to clinical publications and regulatory submissions. Timely and high-quality deliverables are essential, and the role includes budget planning and ensuring that all activities are in line with the study plan.Applicants must have a Master's or Ph.D. in statistics, biostatistics, or mathematics, with a minimum of 15 years' directly relevant experience. Proficiency in SAS programming is required, and experience in R is also necessary. The ideal candidate will have a strong background in oncology therapeutics, including experience with NDA filings, and a proven track record in submitting BLA or NDA filings. A deep understanding of statistical methodologies, including regression models, time-to-event analysis, and adaptive design, is essential. Experience with clinical database software, particularly Medidata RAVE, and knowledge of CDISC standards and validation processes are also required. The role demands a leader who can work effectively with cross-functional teams, define business requirements, and develop strategies to address health authorities' inquiries.Travel Percent Less than 10%FunctionsData Management/Analytics