Description

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.

Key Skills
Education

Any Graduate

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