Executive Director, Head of Biostatistics

The Company is seeking an Executive Director and Head of Biostatistics to provide statistical and programming expertise across clinical development. Responsibilities include contributing to clinical study design, data analysis and interpretation, and the preparation of scientific publications and regulatory submissions. The role partners with clinical, data management, and operations teams; represents biostatistics in health authority interactions; and oversees outsourced statistical and programming deliverables to ensure quality and timely execution. Additional duties include developing analysis plans, supporting randomization, reviewing protocols and statistical outputs, addressing regulatory inquiries, and maintaining internal code. Candidates must hold a master’s degree in statistics or biostatistics and have at least five years of directly relevant experience, including experience in oncology. Strong R programming skills are required; SAS experience is preferred. Applicants must have supported a BLA or NDA filing and represented biostatistics in health authority interactions. Required expertise also includes clinical data structures, CDISC standards and validation, and applicable GCP, ICH, and FDA requirements. Familiarity with advanced statistical methods and clinical database systems is also expected.