Global Lead Statistical Programmer – Clinical Trials
Company: Sun Pharmaceutical Industries Ltd
Business Unit: Global Development Biometric Sciences (GDBS)
Job Grade: Manager
Location: Mumbai / Gurugram / 100% Remote (for the right candidate)
Job Type: Full-Time
Date Posted: January 3, 2026
About Sun Pharmaceutical Industries Ltd
Sun Pharmaceutical Industries Ltd is one of the world’s leading pharmaceutical companies, committed to advancing global healthcare through innovation, quality, and compliance. At Sun Pharma, professionals are empowered to grow, lead with ownership, and collaborate across global teams to deliver impactful clinical and regulatory outcomes.
Job Overview
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 across Phase I–IV clinical trials, ensuring high-quality deliverables for regulatory submissions and global health authority interactions.
The role requires strong expertise in SAS programming, CDISC standards, regulatory submissions, and cross-functional leadership within global clinical development programs.
Key Responsibilities
Study & Programming Leadership
Lead statistical programming activities for one or more Phase I–IV clinical studies across therapeutic areas.
Serve as programming lead for assigned projects, ensuring timely, compliant, and high-quality deliverables.
Perform end-to-end statistical programming and act as a subject matter expert (SME).
Statistical Programming & Standards
Develop and review SAS programs for SDTM and ADaM datasets in compliance with CDISC standards.
Create and maintain SDTM mapping specifications and ADaM specifications.
Develop Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
Contribute to and maintain standard macros, libraries, and programming processes.
Regulatory Submissions & Compliance
Prepare and review P21 deliverables and complete eCTD packages, including aCRF, define.xml, cSDRG, ADRG, and ARM.
Support submissions to global regulatory authorities such as FDA, EMA, PMDA, and other agencies.
Collaborate with cross-functional teams to address health authority queries and post-submission requests.
Ensure compliance with internal SOPs, regulatory guidance, and submission timelines.
Cross-Functional Collaboration & Mentorship
Work closely with clinical, data management, biostatistics, and regulatory teams globally.
Participate in CRF annotation, SAP review, and TLF specification development.
Mentor and coach junior programmers and new hires, fostering technical excellence and collaboration.
Demonstrate strong ownership, accountability, and leadership in a fast-paced global environment.
Required Qualifications & Experience
Educational Qualifications
Minimum Bachelor’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related discipline.
Experience Requirements
7–8+ years of hands-on experience in statistical programming within the pharmaceutical, biotechnology, CRO, or healthcare industry.
Proven experience supporting clinical trial data processing and regulatory submissions.
Prior experience in oncology therapeutic area is strongly preferred.
Technical Skills
Advanced SAS programming skills in a clinical trial environment.
Strong expertise in CDISC standards (SDTM, ADaM), TAUG, and regulatory guidance.
Experience with regulatory submissions such as NDA, ANDA, and global eCTD filings.
Working knowledge of R, Python, or other programming languages is an added advantage.
SAS certifications are desirable.
Soft Skills & Competencies
Strong analytical, problem-solving, and attention-to-detail skills.
Ability to work independently and collaborate effectively within global, cross-functional teams.
Excellent communication, organizational, and stakeholder management skills.
Demonstrated leadership, mentoring ability, and a continuous improvement mindset.
Travel Requirement
Low
Why Join Sun Pharma?
At Sun Pharma, employee growth and well-being are central to the company culture. You will gain exposure to global clinical programs, regulatory strategy, and leadership opportunities within a highly collaborative and performance-driven environment. This role offers a meaningful opportunity to contribute to life-changing therapies while advancing your career in global clinical development.
Disclaimer
The above job description outlines the general nature and level of work expected for this role. It is not intended to be an exhaustive list of all responsibilities, duties, or qualifications. Sun Pharmaceutical Industries Ltd reserves the right to modify job responsibilities in accordance with business requirements.
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