Statistician Role
\
The role of a statistician involves working on clinical trials, producing and validating complex outputs to excellent quality while adhering to deliverable timelines.
Responsibilities include producing and reviewing Statistical Analysis Plans (SAPs), protocols, and other pertinent study documentation. The lead statistician within a reporting team environment is responsible for statistical aspects of reporting out study results.
\
Key Responsibilities:\
\
1. Program and validate complex primary efficacy datasets
\
2. Program and validate complex summary tables, listings, and figures, program statistical analysis tables according to the SAP
\
3. Liaise with clients to propose alternatives or additional analyses if needed
\
4. Develop and validate macros for statistical analyses and figures
\
5. Advise on complex analyses and endpoints; ensure consistency across clinical trial program
\
6. Create, validate, and QC of efficacy dataset specifications for single studies, ISS/ISEs, etc
\
7. Write ISS/ISE SAPs; DSMB SAPs and Charters
\
8. Write project-level or therapeutic area level documentation
\
9. Perform QC of SAP text and develop standard SAP text and templates to be used within the company
\
],