Job Title
Manager 1 – Statistical Programming
Company
Sun Pharmaceutical Industries Ltd
Business Unit
Global Clinical Development
Location
Gurgaon (R&D) / Remote / Hybrid
Job Grade
G10
Experience Required
8+ years in clinical trial programming within pharmaceutical, biotech, CRO, or healthcare industry
Educational Qualification
Bachelor’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or related discipline
Job Overview
The Manager 1 – Statistical Programming will lead and support statistical programming activities across clinical studies, ensuring high-quality and timely delivery of programming outputs for clinical development, regulatory submissions, and ad hoc analyses. The role requires close collaboration with internal stakeholders, external vendors, and cross-functional global teams.
Key Responsibilities
Leadership & Project Delivery
Lead statistical programming activities for assigned therapeutic areas or compounds across multiple studies
Ensure timely and high-quality delivery of all programming outputs
Plan, track, and manage deliverables in coordination with study teams and management
Clinical Data Standards & Programming
Develop SDTM mapping specifications and ADaM specifications based on CDISC standards
Create and validate SAS programs for SDTM, ADaM datasets, and TLFs (Tables, Listings, Figures)
Ensure compliance with CDISC, regulatory guidelines, and internal standards
Documentation & Regulatory Support
Maintain programming documentation and study-level specifications
Support regulatory submissions (FDA, EMA, PMDA, etc.)
Prepare and manage submission packages including aCRF, define.xml, cSDRG, ADRG, ARM, and eCRT deliverables
Standards & Process Development
Contribute to development of standard SAS macros
Participate in establishing and maintaining programming standards and SOPs
Support CRF annotation and SAP review processes
Collaboration & Stakeholder Management
Work with global cross-functional teams and external vendors
Address regulatory authority queries during submissions
Mentorship & Capability Building
Mentor and coach junior programmers and new hires
Contribute to training programs and SME initiatives
Required Skills & Competencies
Strong SAS programming skills in clinical data environment
Knowledge of CDISC standards (SDTM, ADaM) and regulatory guidelines
Understanding of clinical trial processes and statistical concepts
Exposure to regulatory submissions (NDA, ANDA, etc.)
Knowledge of R or Python is an advantage
Strong analytical, problem-solving, and documentation skills
Excellent communication and stakeholder management skills
Ability to work independently and in global teams
Leadership and mentoring capability
Core Attributes
Ownership and accountability
Collaboration and teamwork
Innovation and continuous improvement mindset
Strong organizational skills
Positive attitude and adaptability
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
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Greece |North Island :
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Manila |Croatia :
Croatia |Zagreb :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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