Clinical SAS Programmer

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 documentation.
• Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations.
• Good understanding of the statistical programming domain and related processes.
• Assists with developing, monitoring, and enforcing productivity and quality standards along with related documentations.
• Coordinating with the project management in meeting the timeline and defining / capturing the metrics for monitoring and maintaining the quality and productivity.

Requirements :