Statistical Programmer
Company: Sun Pharmaceutical Industries Ltd. (Sun Pharma)
Job Title: Statistical Programmer
Location: Remote / Hybrid
Posted On: 20 June 2026
Salary: ₹8–20 LPA (India, estimated for 2–12+ years experience) / USD $90,000–$130,000 (global equivalent, depending on experience, CDISC/SAS expertise, and regulatory exposure)
Job Summary
Sun Pharma is seeking an experienced Statistical Programmer to support clinical development and regulatory submissions. The role involves end-to-end statistical programming activities, ensuring high-quality deliverables for clinical studies, submissions, and ad hoc analyses.
The candidate will work closely with cross-functional teams, global stakeholders, and external partners to deliver programming outputs aligned with regulatory standards and timelines.
Key Responsibilities
Lead statistical programming activities across multiple clinical studies and therapeutic areas
Develop and maintain programming documentation as per internal standards
Create CDISC-compliant SDTM and ADaM datasets and mapping specifications
Develop SAS programs for datasets, Tables, Listings, and Figures (TLFs)
Build and maintain standard SAS macros and programming frameworks
Participate in CRF annotation and SAP review
Review TLF specifications and ensure quality deliverables
Manage regulatory submission packages (e.g., aCRF, define.xml, cSDRG, ADRG, ARM)
Support global regulatory submissions (FDA, EMA, PMDA, etc.)
Address Health Authority queries during submissions
Contribute to SOP development, standards, and departmental initiatives
Mentor junior programmers and support team development
Ensure timely delivery of high-quality programming outputs
Technical Skills & Expertise
Strong proficiency in SAS programming in clinical trial environments
Working knowledge of R or Python (preferred)
Strong understanding of clinical trial design and statistical concepts
Hands-on experience with CDISC standards (SDTM, ADaM)
Knowledge of regulatory guidelines (FDA, EMA, ICH, etc.)
Experience in regulatory submissions (NDA, ANDA, etc.)
Ability to develop and validate datasets, TLFs, and analysis outputs
SAS certification is an added advantage
Eligibility Criteria
Bachelor’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or related field
2–12+ years of experience in clinical statistical programming
Experience in pharmaceutical, CRO, biotech, or healthcare industry
Strong analytical, problem-solving, and communication skills
Ability to work independently and within global teams
Leadership or mentoring experience preferred for senior levels
Work Environment
Remote or hybrid work model
Collaboration with global cross-functional teams
Exposure to regulatory submission projects
Opportunity to work on multiple therapeutic areas
Career Development
Opportunity to lead global programming projects
Exposure to FDA/EMA/PMDA regulatory submissions
Development of CDISC and advanced SAS expertise
Mentorship and leadership opportunities
Participation in global SOP and standards development
About Sun Pharma
Sun Pharmaceutical Industries Ltd. is one of the world’s leading pharmaceutical companies, focusing on innovative and affordable medicines. The company operates globally across multiple therapeutic areas and is committed to continuous improvement, collaboration, and scientific excellence.
Employee Value Proposition
Continuous learning and skill development
Global exposure in clinical and regulatory programming
Collaborative and innovation-driven culture
Career advancement opportunities
Strong focus on work-life balance and employee well-being
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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