- Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, SDTM datasets, SDTM Define.xml, SDRG, Annotated CRFs)
- Generating SDTM domains
- Providing programming input to CRFs, SAPs, analysis file specifications, and tables, figures, and listings (TFLs) shells;
- Contributing to the creation, maintenance, and validation of standards for outputs and SAS macros.
- Working knowledge of Pinnacle 21
- Bachelor’s degree in computer science, statistics, mathematics, life sciences or other relevant degree.
- 7 years of statistical programming experience in the pharmaceutical/biotechnology industry.
- Strong understanding of CDISC SDTM requirements/models and experience in implementing these models
- In-depth knowledge of FDA/ICH guidelines and industry/technology standard practices.
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