Global Lead Statistical Programmer
Date Posted: January 3, 2026
Company: Sun Pharmaceutical Industries Ltd
Business Unit: Global Development Biometric Sciences (GDBS)
Job Grade: Manager
Location Options: Mumbai / Gurugram, India | 100% Remote (for the right candidate)
Work Location: Gurgaon – R&D
Employment Type: Full-time
About Sun Pharmaceutical Industries Ltd
Sun Pharmaceutical Industries Ltd is a global leader in specialty and generic pharmaceuticals, committed to advancing clinical research and regulatory excellence worldwide. At Sun Pharma, professionals are empowered to grow, take ownership, and collaborate across global teams in a high-performance, innovation-driven environment.
Job Overview
Sun Pharma is seeking an experienced Global Lead Statistical Programmer to lead end-to-end statistical programming activities across Phase I–IV clinical studies. This leadership role is critical in ensuring high-quality programming deliverables for clinical study reports, regulatory submissions, and global health authority interactions.
The ideal candidate will bring deep expertise in SAS programming, CDISC standards (SDTM/ADaM), regulatory submissions, and global clinical development, with the ability to mentor teams and drive programming excellence across multiple studies and therapeutic areas.
Job Purpose
Lead statistical programming activities for one or more Phase I–IV clinical studies in alignment with project strategies
Independently implement programming standards and deliverables supporting clinical studies, regulatory submissions, and ad hoc analyses
Partner closely with cross-functional stakeholders and external service providers to ensure timely, high-quality outputs
Contribute to the development and continuous improvement of programming standards, macros, libraries, and processes
Key Roles & Responsibilities
Lead statistical programming activities across multiple studies, compounds, or therapeutic areas to ensure regulatory-ready deliverables
Develop and maintain programming documentation in compliance with internal standards and processes
Create and review CDISC-compliant SDTM and ADaM specifications, including mapping documents
Develop and oversee SAS programs for SDTM, ADaM datasets, and Tables, Listings, and Figures (TLFs)
Contribute to the development and maintenance of standard and utility macros
Participate in CRF annotation, SAP review, TLF specification development, and TLF review
Manage all P21-related deliverables and eCRT packages, including aCRF, define.xml, cSDRG, ADRG, and ARM
Support global regulatory submissions to FDA, EMA, PMDA, and other health authorities in compliance with eCTD and regulatory guidance (sdTCG, DSC, etc.)
Address health authority queries in collaboration with cross-functional teams
Ensure all programming activities comply with internal SOPs, timelines, and quality standards
Act as a Subject Matter Expert (SME) for statistical programming and regulatory deliverables
Mentor and coach junior programmers and new hires, fostering a collaborative and high-performance team culture
Educational Qualifications
Bachelor’s degree (minimum) in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related discipline
Experience Required
7 to 8+ years of hands-on experience in statistical programming for clinical trials within the pharmaceutical, biotechnology, CRO, or healthcare industry
Prior experience leading programming activities across multiple studies or therapeutic areas
Oncology therapeutic area experience preferred
Technical Skills & Competencies
Strong expertise in SAS programming within a clinical data environment
Extensive experience implementing CDISC standards (SDTM, ADaM, TAUG)
Solid understanding of clinical development, statistical concepts, and regulatory submissions (NDA, ANDA, etc.)
Working knowledge of R, Python, or other programming languages is an advantage
Experience with global regulatory submissions and health authority interactions
Excellent analytical, problem-solving, and attention-to-detail skills
Ability to work independently and collaborate effectively with global, cross-functional teams
Strong communication, organizational, and leadership capabilities
SAS certification is a plus
Travel Requirement
Low
Why Join Sun Pharma
At Sun Pharma, your growth and well-being are a priority. We offer a collaborative global work culture, exposure to complex clinical development programs, and opportunities to lead high-impact regulatory submissions. Join us to build a meaningful career where your expertise contributes to improving patient outcomes worldwide.
Disclaimer
This job description outlines the general scope and level of responsibilities associated with the role. It is not intended to be an exhaustive list of duties or qualifications. Sun Pharmaceutical Industries Ltd reserves the right to modify responsibilities or assign additional duties based on organizational needs and candidate experience.
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