Job Description
Responsibilities:
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, , 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 ...