Global Lead Statistical Programmer
Location: Mumbai / Gurugram, India (100% Remote option for the right candidate)
Employment Type: Full-Time
Business Unit: Global Development Biometric Sciences (GDBS)
Company: Sun Pharmaceutical Industries Ltd
Job Grade: Manager
Posting Date: December 5, 2025
Experience Required: 7–10+ Years
Job Overview
Sun Pharmaceutical Industries Ltd 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, supporting global regulatory submissions and ensuring high-quality, compliant programming deliverables.
The role offers flexibility in work location, including Mumbai, Gurugram, or full remote, and provides the opportunity to work on global clinical development programs within a highly collaborative, innovation-driven environment.
Key Responsibilities
Leadership & Programming Oversight
Lead statistical programming activities for one or more Phase I–IV clinical studies in alignment with project strategies and timelines.
Act as Programming Lead or Subject Matter Expert (SME) for assigned compounds, indications, or therapeutic areas.
Plan, manage, and deliver high-quality programming outputs while ensuring compliance with internal SOPs and global regulatory standards.
Clinical Data Standards & Deliverables
Develop and maintain programming documentation in accordance with established standards and processes.
Create and review CDISC-compliant SDTM and ADaM specifications, including mapping documents.
Develop, validate, and review SAS programs for SDTM, ADaM datasets, and Tables, Listings, and Figures (TLFs).
Participate in CRF annotation, SAP review, TLF specification development, and TLF review activities.
Regulatory Submission Support
Manage P21-related activities and complete 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 sdTCG, DSC, and eCTD requirements.
Collaborate with cross-functional partners to address regulatory queries and health authority requests.
Process Improvement & Collaboration
Contribute to the development and maintenance of standard macros, utilities, libraries, and programming processes.
Ensure programming deliverables meet regulatory quality, consistency, and submission-readiness standards.
Work closely with internal stakeholders and external service providers to ensure timely and high-quality delivery.
Mentorship & Team Development
Mentor, coach, and guide junior programmers and new hires.
Promote a culture of collaboration, ownership, innovation, and continuous improvement.
Required Qualifications & Experience
Education
Bachelor’s degree (minimum) in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related discipline.
Advanced degrees are an advantage.
Experience
7–10+ years of hands-on statistical programming experience in the pharmaceutical, biotechnology, CRO, or healthcare industry.
Prior experience leading programming activities across multiple clinical studies.
Oncology therapeutic area experience is preferred.
Technical Skills & Competencies
Advanced SAS programming expertise in a clinical trials environment
Strong working knowledge of CDISC standards (SDTM, ADaM), TAUGs, and regulatory guidance
Experience supporting NDA, ANDA, and global regulatory submissions
Exposure to additional programming languages such as R or Python is a plus
Strong analytical, problem-solving, and documentation skills
Excellent communication, organizational, and stakeholder management abilities
Ability to work independently and collaboratively within global, cross-functional teams
SAS certification is an added advantage
Travel Requirement
Low travel requirement
Why Join Sun Pharma
Sun Pharma fosters a culture of continuous growth, accountability, and collaboration. Employees are empowered to lead, innovate, and contribute to impactful global healthcare solutions while benefiting from strong professional development opportunities and a flexible work environment.
SEO Keywords for Global Reach
Global Lead Statistical Programmer jobs, SAS Programmer jobs India, Biostatistics programming careers, CDISC SDTM ADaM jobs, Clinical trial programming roles, Remote SAS programming jobs, Sun Pharma careers.
Disclaimer
This job description is intended to describe the general nature and level of work performed by employees in this role. It is not intended to be an exhaustive list of responsibilities or qualifications. Sun Pharmaceutical Industries Ltd reserves the right to modify job duties in line with business requir
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