Job Description

• 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 Required:-  All the responsibilities mentioned above are in line with the professional background and requires an absolute minimum of a Bachelor’s degree in computer science, computer information systems, information technology or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned subjects.

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