Director, Biostatistics

Job description

Job Description We are seeking an experienced Director, Biostatistics to serve as Study Statistician across one or more drug development programs. This individual will provide statistical strategy from early development through regulatory submission, partnering cross-functionally to drive data-informed decision-making and ensure scientific and regulatory excellence. Key Responsibilities: - Provide statistical strategy and oversight for multiple clinical studies or programs across all phases of development - Contribute to Clinical Development Plans and represent Biostatistics on cross-functional teams - Design studies, author and review protocols and Statistical Analysis Plans (SAPs), and oversee interim and final analysis - Ensure quality, accuracy, and reproducibility of statistical outputs in collaboration with programming teams and CROs - Support regulatory submissions (INDs, NDAs, BLAs, MAAs), including health authority interactions and integrated summaries (ISS/ISE) - Provide oversight of external vendors and mentor junior statisticians or contractors - Contribute to publications, conference presentations, and continuous improvement initiatives Qualifications: - PhD in Statist...