About the position Responsibilities • Provide support to a clinical study team on all relevant statistical matters under direct supervision. • Participate in the preparation of study protocol and amendments. • Perform relevant sample size calculations and write the statistical methodology section of the protocol. • Review case report forms (CRF) and provide comments and feedback. • Develop statistical analysis plans (SAP). • Provide programming team with definitions and documentation for derived variables needed to produce planned Tables, Figures, and Listings (TFLs). • Develop data and programming specifications jointly with programmers. • Perform statistical analysis according to the SAP, validate analysis programs, and review TFLs. • Prepare statistical methods and results sections for the clinical study report (CSR). • Provide statistical insight into interpretation and discussion of study results. • Support project-related activities including preparation of BLA submissions and oversee CRO deliverables. Requirements • Master's degree in Statistics/Biostatistics or related field required. • 2+ years of relevant experience in early phase clinical trials. Apply tot his job