Job Title: Global Lead Statistical Programmer
Company: Sun Pharmaceutical Industries Ltd
Business Unit: Global Development Biometric Sciences (GDBS)
Job Grade: Manager
Date Posted: February 1, 2026
Location: Mumbai / Gurugram, India (100% Remote option available for the right candidate)
Employment Type: Full-Time
Sun Pharmaceutical Industries Ltd is a global, research-driven pharmaceutical organization committed to delivering high-quality, affordable medicines worldwide. With a strong focus on innovation, compliance, and scientific excellence, Sun Pharma offers professionals an opportunity to contribute to global drug development programs while growing in a collaborative and performance-driven environment.
Sun Pharma is seeking an experienced Global Lead Statistical Programmer to join its Global Development Biometric Sciences (GDBS) team. This leadership role is responsible for end-to-end statistical programming activities across Phase I–IV clinical studies, supporting regulatory submissions and global development strategies.
The role requires strong expertise in SAS programming, CDISC standards, regulatory submissions, and cross-functional collaboration in a global clinical development environment.
Lead statistical programming activities for one or more Phase I–IV clinical studies, ensuring alignment with project strategies and timelines.
Act as programming lead for assigned therapeutic areas, compounds, or indications across multiple studies.
Perform and oversee end-to-end programming activities as a subject matter expert.
Develop, review, and maintain programming documentation in compliance with internal standards and SOPs.
Create and review CDISC-compliant SDTM mapping specifications and ADaM specifications.
Develop and oversee SAS programs for SDTM, ADaM datasets, and Tables, Listings, and Figures (TLFs).
Contribute to the development and maintenance of standard macros, utilities, libraries, and programming processes.
Handle P21-related activities and prepare complete eCRT packages, including aCRF, define.xml, cSDRG, ADRG, and ARM.
Support global regulatory submissions (FDA, EMA, PMDA, and other health authorities) in accordance with sdTCG, DSC, and eCTD requirements.
Collaborate with cross-functional teams to respond to health authority queries and requests.
Work closely with statisticians, data management, clinical teams, regulatory affairs, and external vendors to ensure timely, high-quality deliverables.
Participate in CRF annotation, SAP review, TLF specification development, and TLF review activities.
Ensure all programming outputs meet regulatory, quality, and submission standards.
Adhere to internal SOPs, regulatory guidance, and industry best practices.
Mentor and coach junior programmers and new hires, fostering technical excellence and teamwork.
Educational Qualification:
Bachelor’s degree (minimum) in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related discipline
Experience Required:
7–8+ years of hands-on statistical programming experience in clinical trial data processing within pharmaceutical, biotechnology, CRO, or healthcare industries
Prior experience leading programming activities across multiple studies is required
Preferred Experience:
Oncology therapeutic area experience
Prior Programming Team Lead (PTL) experience
Advanced SAS programming expertise in a clinical data environment
Strong working knowledge of CDISC standards (SDTM, ADaM), TAUGs, and regulatory guidance
Experience supporting global regulatory submissions (NDA, ANDA, FDA, EMA, PMDA)
Knowledge of additional programming languages such as R or Python is an advantage
Strong analytical, problem-solving, and critical-thinking skills
Ability to work independently and effectively within global, cross-functional teams
Excellent communication, organizational, and stakeholder management skills
SAS certifications are an added advantage
Low travel requirement
Sun Pharma offers a dynamic and inclusive work environment with opportunities for global exposure, leadership development, and continuous learning. Employees benefit from robust career growth programs, competitive benefits, and the flexibility to work remotely based on role requirements.
Gujarat :
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Kyiv |Lima Region :
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