Sun Pharma Hiring Subject Matter Expert

Sun Pharma is India’s No. 1 pharmaceutical company and a leading global player in specialty medicines. With over 40 manufacturing facilities and a diverse portfolio, we deliver high-quality medicines across 100 countries. Driven by a commitment to innovation, we continuously strive to enhance access to medicines and improve patient care, creating better health outcomes for millions around the world.

Post : SME, CDISC & eSubmission Standards

Job Description
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. The incumbent will support the implementation of internal standards, provide study-level CDISC guidance, conduct quality reviews of deliverables from CRO partners, and ensure clinical data packages meet inspection-readiness criteria for global health authorities.

In this role, a typical day might include the following :
• 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, ADRG).
• Ensure study-level compliance with defined SDTM and ADaM versions. Assist study teams in handling standards exceptions and applying transitioning rules.
• Author, review, and QC study-level specifications, including annotated CRFs (aCRFs), SDTM/ADaM mapping specifications, and variable-level metadata.
• Execute review workflows and checklists for internal and external deliverables. Conduct hands-on review of CRO-provided SDTM, ADaM, Define-XML, and submission data packages.
• 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.
• Work closely with Biostatistics, Data Management, and Clinical Operations to resolve study-specific standards issues and support on-time delivery.
• Assist in preparing artifacts for audits and inspections. Help train internal teams and vendors on CDISC standards and internal conventions.

Candidate Profile
• Solid working knowledge of CDISC standards (SDTM, ADaM), Define-XML, and Reviewer's Guides (SDRG/ADRG).
• Must have at least 2-3 years of previous experience working as a CDISC SME at another organization.
• Hands-on experience with Pinnacle 21 Community/Enterprise and a good understanding of data traceability.
• Experience reviewing and QCing CRO deliverables and maintaining issue logs.
• Strong communication skills with the ability to collaborate effectively within cross-functional study teams.
To Be Considered For This Opportunity You Must Have
• Minimum Bachelor’s degree in Life Sciences, Statistics, Computer Science, Data Science, or a related field required with 8+ years of relevant pharmaceutical or biotechnology industry experience with strong hands-on statistical programming and CDISC standards expertise.

Additional Information
Experience : 2-3 years
Qualification : Bachelor’s degree in Life Sciences
Location : Gurgaon - R&D
Business Unit : Global Clinical Development
Job Grade : Manager, G10
End Date : 15th November 2026