Executive Director, Biostatistics

The Company is seeking a senior biostatistics leader to guide its function and provide strategic and operational oversight across clinical development programs. The role will shape study design, statistical and regulatory strategies, and key program decisions from early development through registration, while ensuring high-quality, timely statistical deliverables. Responsibilities include leading Phase 1–3 trial strategy, evaluating innovative designs, supporting biomarker-driven development, and contributing to global regulatory interactions and submissions. The leader will oversee analysis plans, datasets, reports, external partners, processes, and resources, while providing hands-on technical expertise and mentoring statistical teams. Candidates should have a PhD in biostatistics, statistics, or a related quantitative field and at least 12 years of relevant industry experience, or a master’s degree and at least 15 years. Extensive oncology drug development experience, including leadership in Phase 3 registrational trials, is required, along with expertise in clinical trial methodology, adaptive and Bayesian designs, and biomarker strategies. Applicants should bring knowledge of regulatory submissions, ICH guidelines, GCP, and CDISC standards, as well as strong SAS and R skills. Proven leadership, communication, cross-functional collaboration, and experience managing external partners are also important.