SME, CDISC & eSubmission Standards

About the role

The CDISC & eSubmission Standards Subject Matter Expert (SME) at the Manager level will provide hands-on expertise for CDISC standards (SDTM, ADaM, Define-XML, Controlled Terminology) and regulatory submission support. This role is a key part of our Biometrics Innovation and Statistical Programming team.

What you'll do

• Contribute to the development and maintenance of internal CDISC and submission standards, templates, and SOPs for SDTM, ADaM, Define-XML, and Reviewer’s Guides (cSDRG
• Ensure study-level compliance with defined SDTM and ADaM versions. Assist study teams in handling standards exceptions and applying transitioning rules
• Execute review workflows and checklists for internal and external deliverables. Conduct hands-on review of CRO-provided SDTM, ADaM, Define-XML
• Assist in assembling and verifying eCTD data package structures. Support NDA/BLA submissions by generating or reviewing data-related artifacts
• Run and review Pinnacle 21 (or similar) validation outputs. Investigate findings, draft justifications, and verify SDTM → ADaM → TLF traceability for endpoints

What you need

• 8–14 yrs of experience
• Regulatory affairs
• CRO
• SOP writing
• Communication
• B.Tech or B.E. or B.Sc or BCA