该职位来源于猎聘 Key responsibilities and skills may include, but are not limited to:
- Analyze data and report statistical results.
- Develop SDTM specifications for programming datasets following CDISC standard.
- Independently develop SAS programs to create SDTM datasets.
- Develop ADaM analysis data specifications for programming following CDISC standard with minimum supervision.
- Independently develop SAS programs to create ADaM datasets for Analysis and Reporting based on Statistical Analysis Plan.
- Develop, debug, and maintain SAS programs and macros to create Tables, Listings and Graphs for Clinical Study Report following CDISC, industry guidelines and Statistical Analysis Plan.
- Independently implement SAS programs to generate Define-XML package for FDA submission.
- Develop SAS programmable edit checks to assist data monitoring, document and report data issue to Data Management.
- Implement statistical data analysis and communicate with statisticians for statistical input.
- Support regulatory electronic submissions to Food and Drug Administration (FDA) and other worldwide regulatory authorities.
- Perform other programming tasks as needed per management requests.