Senior Manager, Biostatistics
Core
Lead statistician for oncology clinical studies, providing statistical leadership from protocol development through regulatory submission.
Role type
Senior Manager, Biostatistician (Oncology Clinical Development)
Builds
Clinical Study Reports (CSRs), regulatory submission documents, and analysis datasets for oncology trials.
Domain
Pharmaceutical / Oncology Clinical Trials
Required skills
SAS programming, statistical principles, clinical trial methodology, FDA/EMA/PMDA/ICH regulatory guidelines, CDISC standards (SDTM/ADaM), protocol development, Statistical Analysis Plan (SAP) authoring, Clinical Study Report (CSR) preparation, regulatory submission support, cross-functional collaboration, mentoring junior statisticians
Preferred skills
R programming, oncology clinical development experience, CRO/vendor management experience
Technologies
SAS, R, CDISC (SDTM, ADaM)
Responsibilities
Lead one or more oncology clinical studies; provide input on study design, endpoints, sample size, and analysis strategy; author and review SAPs; review statistical outputs and TLFs; interpret results and communicate to project teams; contribute to CSRs, abstracts, and regulatory documents; support regulatory submissions; ensure compliance with industry standards; mentor junior staff
Seniority
Senior Manager, hands-on IC with leadership responsibilities
