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.
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Remote, India | Siliguri |Illinois :
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
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Warsaw |