Sr. SAS Programmer (Clinical Data Services SDTM)

We are looking for an experienced Clinical Data Services Senior Analyst with strong expertise in Clinical Data Management, CDISC standards, and SDTM mapping. The role will support Life Sciences R& D projects by analyzing clinical trial source data, developing SDTM domains, preparing mapping specifications, performing quality control, and ensuring high-quality regulatory and client deliverables.

Responsibilities:

• Review and analyze clinical trial source/raw data.
• Author mapping specifications from source data to CDISC/SDTM and client-defined standards.
• Develop CDISC and SDTM domains using data conversion/mapping tools.
• Perform quality control (QC) of SDTM domain outputs.
• Create and maintain data definition files and CRF/eCRF annotations based on CDISC/SDTM standards.
• Support clinical data management activities, including discrepancy review, query generation, and query resolution.
• Support creation of CRF Completion Guidelines (CCG) and SAE reconciliation guidelines.
• Identify and raise protocol deviations in clinical databases.
• Support edit check validation, including test case and test script creation.
• Perform database validation/UAT against specified CRF/eCRF requirements.
• Prepare project status reports and maintain project-related documentation.
• Proactively identify project issues, analyze root causes, and contribute to effective solutions.
• Ensure accuracy, consistency, and quality of internal and external deliverables.
• Collaborate with peers, clients, and management as required.
• May oversee a small work effort or guide junior team members.

Requirements:

• Experience: 5-8 Years.
• Qualification: BE / BTech.
• Strong experience in SDTM mapping.
• Hands-on knowledge of CDISC standards.
• Understanding of SDTM domains and structures.
• Experience with clinical trial data and raw/source data analysis.
• Knowledge of Clinical Data Management (CDM) processes.
• Experience in mapping specifications and data conversion.
• Experience with SDTM domain development and QC.
• Knowledge of CRF/eCRF annotation and data definition files.
• Understanding of edit checks, database validation, UAT, and test scripts.
• Knowledge of clinical trial documentation and regulatory data standards is preferred.