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Dgm, Statistical Programming

Sun Pharma
15-18 years
Not Disclosed
Gurgaon, Gurugram, Remote, India, India
10 May 26, 2026
Job Description
Job Type: Full Time Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Deputy General Manager (DGM) – Statistical Programming
(Associate Director / Senior Leadership Role)

Location

Gurgaon, India (Remote/Hybrid)

Department

Global Clinical Development – R&D

Company

Sun Pharmaceutical Industries Ltd


Role Overview

The DGM – Statistical Programming is a senior leadership role responsible for managing large-scale clinical statistical programming operations, leading global teams, and ensuring high-quality, regulatory-compliant deliverables for complex clinical trials and global submissions.

This role combines deep technical SAS/CDISC expertise with strong people leadership and strategic oversight.


Key Responsibilities

1. Leadership & Team Management

  • Lead, manage, and mentor large teams of statistical programmers

  • Build capability and performance within programming teams

  • Drive staff development, training, and performance management

  • Ensure efficient resource allocation across global projects


2. Statistical Programming Strategy & Execution

  • Lead programming activities across multiple therapeutic areas and studies

  • Ensure timely and high-quality delivery of all programming outputs

  • Oversee SDTM and ADaM dataset development using CDISC standards

  • Guide creation of statistical outputs (Tables, Listings, Figures)


3. CDISC Standards & Clinical Data Management

  • Develop and maintain SDTM and ADaM specifications

  • Ensure adherence to CDISC standards and regulatory expectations

  • Contribute to development of macros, templates, and programming standards

  • Ensure consistency across global datasets and studies


4. Regulatory Submission Support

  • Lead preparation of regulatory submission packages including:

    • define.xml

    • aCRF

    • cSDRG / ADRG

    • ARM documents

  • Support global submissions to:

    • FDA

    • EMA

    • PMDA

  • Address Health Authority queries and inspection readiness


5. Cross-Functional Collaboration

  • Work with Clinical, Biostatistics, Regulatory, and Data Science teams

  • Align programming deliverables with study and submission strategy

  • Coordinate with external vendors and service providers

  • Ensure alignment across global stakeholders


6. Quality, Compliance & Standards

  • Ensure compliance with SOPs, GxP, and regulatory guidelines

  • Maintain audit-ready documentation and processes

  • Validate programming tools and datasets as per standards

  • Drive continuous improvement in programming quality systems


7. Strategic Contribution & SME Role

  • Act as Subject Matter Expert (SME) in statistical programming

  • Contribute to departmental strategy, SOPs, and innovation initiatives

  • Support development of new standards and automation tools

  • Provide technical guidance for complex programming challenges


8. Clinical Programming Deliverables

  • Support CRF annotation and SAP review

  • Review TLF specifications and outputs

  • Ensure accurate programming implementation of study designs

  • Oversee complex multi-study and multi-indication programs


Required Qualifications

Education

  • Bachelor’s degree in:

    • Statistics

    • Computer Science

    • Mathematics

    • Engineering

    • Life Sciences

    • Or related discipline


Experience

  • 15–18+ years in clinical statistical programming

  • Extensive leadership experience in pharmaceutical/CRO/biotech industry

  • Proven experience managing large global programming teams


Key Technical Skills

  • Expert-level SAS programming in clinical environment

  • Strong knowledge of R (preferred)

  • Deep expertise in CDISC standards (SDTM, ADaM)

  • Strong understanding of clinical development lifecycle (Phase I–IV)

  • Experience in NDA / ANDA / global regulatory submissions

  • Knowledge of ICH guidelines and global regulatory frameworks

  • Experience in SAP, TLF, and clinical analysis planning


Soft Skills

  • Strong leadership and team management ability

  • Excellent communication and stakeholder management skills

  • Strategic thinking and decision-making ability

  • High accountability and ownership mindset

  • Strong problem-solving and innovation orientation

  • Ability to manage multiple complex global projects


Core Function

This role ensures strategic leadership of statistical programming operations, enabling high-quality clinical trial data outputs and regulatory submissions across global drug development programs.


About the Company

Sun Pharmaceutical Industries Ltd is a global pharmaceutical leader in specialty and generic medicines, with strong capabilities in clinical development, regulatory submissions, and large-scale R&D operations worldwide.