Global Lead Statistical Programmer – Clinical Trials
Company: Sun Pharmaceutical Industries Ltd
Business Unit: Global Development Biometric Sciences (GDBS)
Job Location: Gurgaon / Mumbai / 100% Remote (for qualified candidates)
Job Type: Full-Time, Manager Level
Experience Required: 7–8+ Years
Posted Date: January 3, 2026
Job Overview
Sun Pharma is seeking a Global Lead Statistical Programmer to drive statistical programming for global clinical trials across multiple therapeutic areas, with a preference for oncology studies. This role is ideal for professionals with deep expertise in SAS programming, CDISC standards, and clinical data processes, who can lead global teams, mentor junior programmers, and ensure high-quality regulatory submission deliverables.
As a key member of our Global Development Biometric Sciences (GDBS) team, you will contribute to end-to-end statistical programming activities, including database creation, SDTM/ADaM datasets, TLFs, and regulatory submission packages for FDA, EMA, PMDA, and other authorities.
Key Responsibilities
Lead statistical programming activities for Phase I–IV clinical studies across multiple projects and therapeutic areas
Develop, validate, and maintain CDISC-compliant SDTM and ADaM datasets
Generate Tables, Listings, and Figures (TLFs) and contribute to statistical analysis reporting
Participate in CRF annotation, SAP review, and TLF specification development
Manage regulatory submission packages, including P21 compliance, define.xml, cSDRG, ADRG, ARM, ensuring alignment with global submission standards
Support global regulatory authority submissions, addressing queries and collaborating with cross-functional teams
Mentor and coach junior programmers and new hires, promoting best practices and standardization
Develop and maintain reusable macros, libraries, and programming standards
Ensure adherence to internal SOPs, timelines, and quality standards for all deliverables
Collaborate effectively with internal stakeholders, functional service providers, and external teams for timely and high-quality project execution
Required Qualifications
Bachelor’s degree in Statistics, Mathematics, Computer Science, Engineering, Life Sciences, or related discipline
7–8+ years of programming experience in clinical trials within pharma, biotech, CRO, or healthcare industry
Strong SAS programming skills in clinical data environments
Solid understanding of CDISC standards (SDTM/ADaM), regulatory submissions, and statistical analysis principles
Working knowledge of other programming languages such as R or Python is a plus
Oncology therapeutic area experience preferred
Prior experience in leading programming teams and global projects (PTL experience a plus)
Skills and Competencies
In-depth knowledge of pharmaceutical clinical development and statistical concepts
Strong analytical, problem-solving, and attention-to-detail skills
Excellent communication, organizational, and interpersonal skills
Ability to work independently and in global, cross-functional teams
Positive attitude, collaborative mindset, and ability to mentor and guide team members
Adaptable to fast-paced, dynamic clinical research environments
Travel
Minimal travel required
Why Join Sun Pharma?
Join a globally recognized pharmaceutical company where your expertise will directly impact the development of life-changing therapies. Benefit from exposure to international clinical trials, opportunities for professional growth, mentoring, and collaboration with global teams. Be part of a culture that prioritizes excellence, innovation, and the well-being of its employees.
Gujarat :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
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