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
Requirements:
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
