SME CDISC And ESubmission Standards

SUN PHARMA; Gurugram District; Híbrido; INR 1.800.000 - 2.600.000; Tempo integral

Resumo da vaga

Sun Pharma is seeking a CDISC & eSubmission Standards Subject Matter Expert (SME) at the Manager level to provide hands-on expertise in SDTM, ADaM, Define-XML, and regulatory submission support within the Biometrics Innovation and Statistical Programming team.

You will develop internal standards, guide study teams, review CRO deliverables, validate data packages with Pinnacle 21, and help ensure inspection readiness for global health authorities while collaborating with Biostatistics, Data

Qualificações

• 8+ years of pharma/biotech experience with CDISC expertise.
• Hands-on statistical programming experience.
• Experience with Pinnacle 21 Community/Enterprise.
• Ability to review and QC CRO deliverables and maintain issue logs.
• Strong cross-functional communication and collaboration.

Responsabilidades

• Contribute to internal CDISC standards, templates, and SOPs (SDTM/ADaM/Define-XML).
• Ensure study-level SDTM/ADaM compliance and manage exceptions.
• Author, review, and QC study-level specs, aCRFs, and mappings.
• Run internal and CRO data package reviews for SDTM/ADaM/Define-XML.
• Assist in assembling eCTD data structures and NDA/BLA artifacts.
• Run Pinnacle 21 validations and draft justifications for findings.
• Collaborate with Biostatistics, Data Management, and Clinical Operations.
• Prepare artifacts for audits and train internal teams on CDISC standards.

Conhecimentos

CDISC standards

SDTM

ADaM

Define-XML

Reviewer's Guides

Data traceability

Communication skills

Formação

Bachelor's degree in Life Sciences, Statistics, Computer Science, Data Science, or a related field

Ferramentas

Pinnacle 21

Descrição da vaga

Job Description:

Title: SME, CDISC & eSubmission Standards

Business Unit: Global Clinical Development

Job Grade: Manager, G10

Location: Hybrid/Remote

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.

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.

This Role May Be For You If Have

• 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.

Your Success Matters to Us

At Sun Pharma, your success and well‑being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).