Senior Manager, Biostatistics
Core
Senior Manager leading biostatistics for clinical trial design, analysis planning, and regulatory submissions.
Role type
Senior Manager, Biostatistics
Builds
Clinical study reports, statistical analysis plans, regulatory submissions, and publications
Domain
Pharmaceutical / Biostatistics
Required skills
SAS, R, Python, advanced statistical analysis, data manipulation, graphing, simulation, clinical trial design, regulatory requirements, drug development process
Preferred skills
Standard and advanced statistical methods, regulatory requirements, clinical trial design
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 ways to maximize clarity of data display; 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 how it is appropriately applied in trial design and data analysis; Continually enhance knowledge of drug development process, regulatory and commercial requirement; Develop & advise team members