Sr. SDTM Programmer

Responsibilities:

• 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

Basic Qualifications:

• 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.