Katalyst Healthcares & Life Sciences


Job Information

Job Description


  • Review protocols for CDISC conformance
  • Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements
  • Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with Emmes' SDTM Implementation Guide, project standards, and the study protocol
  • Create DEFINE specifications for mapping of SDTM and ADaM compliant datasets
  • Review and QC submission ready SDTM datasets, define.xml, and supporting documentation, as appropriate
  • Provide CDISC training and serve as a subject matter support to project staff
  • Maintain and coordinate CDISC standards efforts, ensure maximum reuse of applied standards, involvement in ongoing process improvement efforts and working with teams to provide technical and process guidance
  • Stay current with the evolution of all CDISC standards and be involved in creation and maintenance of process documentation
  • Other duties as assigned
  • Bachelor's degree, scientific discipline preferred with 5+years of experience in the production CDISC-compliant data structures including SDTM and ADaM required
  • SAS Certified Base Programmer certification required
  • Experience with development, documentation, and testing of analysis data and programming code to meet regulatory and company standards
  • Good organizational and communication skills, the ability to work in a collaborative environment, and a desire to improve skills are essential

Katalyst Healthcares & Life Sciences