Biostatistics Director, Oncology Biosimilars- US Remote
Core
Provide strategic statistical input and oversee all statistical aspects of clinical development from early to late phase for multiple biosimilar products across different therapeutic areas.
Role type
Director-level biostatistician (oncology biosimilars)
Builds
Clinical development plans, regulatory submissions, and scientific reports for biosimilar medicines
Domain
Biopharmaceuticals / Oncology
Required skills
Biostatistics, Clinical development strategy, Regulatory submissions, Team leadership, Statistical analysis, Study design
Preferred skills
Oncology therapeutic area expertise, Adaptive designs, Bayesian adaptive design, Combined phase 1/2 or 2/3 design, Life cycle drug development, CRO management
Technologies
SAS, R, Python
Responsibilities
Develop and maintain statistical excellence in design, analysis, and reporting; Review product and study level documents; Manage and develop internal statistical staff; Ensure statistical strategy for clinical development programs; Represent statistical function at meetings with regulatory authorities; Provide oversight to CROs; Publish applied research and present at scientific meetings.
Seniority
Director, strategic leadership & team management