Job Description
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.
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