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.
• 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.
• ssists 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.

• Bachelor's or master's degree in computer science, Management Information Systems, or a related field.
• Minimum of 5 years of experience in using SAS to process and analyze large datasets.
• Experience in conducting data quality reviews including clinical data, tables, graphs, and reports.
• Experience in developing technical documentation.
• 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.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

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