Work Schedule
Second Shift (Afternoons)
Environmental Conditions
Office
Job Description

Principal Programmer Analyst – End-to-End SDTM

Join Us as a Principal Programmer Analyst – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last five years.

As a Principal Programmer Analyst, you will serve as a Study Lead/Lead Programmer with primary responsibility for end-to-end CDISC SDTM programming and delivery across clinical studies.

You will lead SDTM activities from study start-up and specification development through mapping, programming, validation, quality review, final delivery, and regulatory submission support. This position requires extensive hands-on SDTM expertise combined with the ability to independently lead studies, manage programming deliverables, and provide technical oversight and mentoring to programming teams.

What You’ll Do




• Serve as the Study Lead/Lead Programmer and take ownership of end-to-end SDTM programming activities across clinical studies.
• Lead SDTM activities from study start-up through final delivery and submission, ensuring quality, consistency, and compliance with applicable CDISC standards.
• Review study protocols, CRFs, data specifications, and source data to determine SDTM requirements and mapping strategies.
• Develop and review SDTM specifications and mapping documentation.
• Perform and oversee source-to-SDTM mapping across clinical domains.
• Develop, maintain, and validate SDTM datasets using SAS.
• Ensure appropriate implementation of CDISC SDTM/SDTMIG standards and controlled terminology.
• Perform SDTM compliance and quality checks and resolve validation findings.
• Support preparation and quality review of submission-ready SDTM deliverables, including associated documentation.
• Provide technical oversight and conduct peer review/QC of SDTM deliverables produced by oth

📌 Principal Programmer Analyst (Bengaluru)
🏢 Thermo Fisher Scientific
📍 Bengaluru