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Job Discription
LOCATION : PAN INDIA WFH
PRIMARY PURPOSE :
The Lead CDISC SAS Programmer will work exclusively within the corporate CDISC Service Group with primary responsibility for generation of CDISC-compliant data structures for clinical trials. As part of these activities, the CDISC SAS Programmer will map clinical data to ADAM domains following internal Implementation Guides and specific Therapeutic Area Users Guide and work with project teams to create ADaM data structures and any other CDISC materials necessary for regulatory submissions.
RESPONSIBILITIES :
– Review protocols for CDISC conformance.
– Review Case Report Forms and eCRFs with CDISC CDASH and ADAM conformant elements
– Write and manage SAS code for mapping clinical data to ADAM data structures in conformance with the company’s ADAM Implementation Guide, project standards, and the study protocol
– Create DEFINE specifications for mapping of SDTM and ADaM compliant datasets
– Review and QC submission ready ADAM 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
– Provides accurate, effective and timely communication of clinical study and statistical output to internal & external stakeholders
EXPERIENCE :
– Bachelor’s degree, scientific discipline preferred. Minimum 5 years of experience in SAS programming within pharma andor CRO
– SAS Certified Base Programmer certification required
– Experience in the production CDISC-compliant data structures including SDTM and ADaM
– Good knowledge of programming languages (SAS Macros, SQL, STATS, graph and ODS) with understanding of databases
– Experience with development, documentation, and testing of analysis data and programming code to meet regulatory and company standards
– Understanding of GCP principles and other regulatory standards in Clinical Research
– Good analytical skills with the ability to process scientific and medical data
– Good organizational and communication skills, the ability to work in a collaborative environment, and a desire to improve skills are essential
– Experience in therapeutic research areas that will align with Emmes- expertise, including ophthalmology, oncology, vaccine and infectious disease, transplantation or cellular therapy trials, autoimmune disease, neurology, substance use, maternal child health is preferred
