Senior Manager, Biostatistics
Core
Senior Manager of Biostatistics contributing to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions for oncology, hematology, cell therapy, immunology, and cardiovascular disease.
Role type
Senior Manager, Biostatistics
Builds
Clinical study reports, statistical analysis plans, regulatory submissions, and publications for innovative medicines.
Domain
Pharmaceutical / Biotechnology / Clinical Trials
Required skills
Biostatistics, SAS, R, Python, Clinical trial design, Regulatory requirements, Statistical analysis, Data interpretation, Protocol development
Preferred skills
Advanced statistical methods, Drug development process knowledge
Technologies
SAS, R, Python
Responsibilities
Collaborate in design of clinical study including methodology, data analysis & interpretation, and reporting of study results; Author and/or review protocol synopsis, protocol, statistical analysis plans, case-report forms, clinical study reports, associated publications, and other study level specification documents; Perform and/or validate statistical analyses and advise on data display clarity; Communicate results to cross-functional teams and provide data interpretation in study documents; Translate scientific questions into statistical terms and statistical concepts into layman terms; Continually develop technical knowledge of statistical methodology and drug development process; Develop and advise team members.
Seniority
Senior, hands-on IC with leadership responsibilities