Executive Director, Biostatistics

The Company is seeking an Executive Director of Biostatistics to lead the statistical function and set the statistical strategy for clinical programs. The successful candidate will be responsible for providing statistical leadership and expertise in clinical development strategy, clinical trials, and study design. This includes overseeing regulatory submissions, data interpretation, and portfolio decision-making. The role also involves shaping clinical programs, setting outsourcing strategies, and managing both internal and external biostatistics and programming teams. The Executive Director will be the senior statistical representative in global health authority interactions and will be expected to have a strong background in oncology, with a proven track record in leading statistical strategy for successful NDA/BLA submissions. Applicants for the Executive Director of Biostatistics position at the company should have a Ph.D. in Statistics or Biostatistics with at least 12 years of directly relevant experience, or a Master's degree with over 15 years of experience. A background in oncology with recent experience in at least five studies is required. The ideal candidate will have a strong programming skill set in R or SAS, experience with innovative trial designs, and a deep understanding of GCP, ICH, and FDA requirements. The role demands excellent leadership, communication, and interpersonal skills, as well as the ability to work effectively across functions. The Executive Director will be expected to have executive presence and the ability to communicate complex statistical concepts to a wide range of stakeholders.