- Create programs to Develop and maintain SAS programs to create SDTM, ADaM datasets and TFLs.
- Create programs to perform QC of SDTM, ADaMs and TFLs.
- Program in SAS for study report tables/listings/figures to support of final reports, abstracts, posters, manuscripts and other clinical publications.
- Annotation of Case report form’s (CRF) based on CDISC SDTM standards.
- Develop specifications for SDTMs based on CRF and input raw data.
- Create analysis datasets (e.g., ADaM) specifications based on Statistical Analysis Plan (SAP) and TFL shell.
- Review SAPs and TFL shells from a programming perspective for studies.
- Create and review Reviewers Guide for SDTM and ADaM.
- Generate Pinnacle 21 reports and update the programs/provide the comments for conformance checks.
- Generate and validate Define files.
- Support data management by generating data listings.
Minimum Education Requirement:- All the responsibilities mentioned above are in line with the professional background and requires an absolute minimum of a bachelor’s degree or its working equivalent in Computer Science, Computer Information Systems, Information Technology, or a combination of education and experience equating to the U.S. equivalent of Bachelor’s degree in one of the aforementioned subjects.
