Job Title
Manager 1 – Statistical Programming
Location
Gurgaon, India (Remote/Hybrid)
Department
Global Clinical Development – R&D
Company
Sun Pharmaceutical Industries Ltd
Role Overview
The Manager 1 – Statistical Programming is responsible for leading clinical trial programming activities across multiple studies, ensuring high-quality, regulatory-compliant statistical outputs for clinical development and global regulatory submissions.
This role combines hands-on SAS programming expertise with team leadership and regulatory submission support.
Key Responsibilities
1. Statistical Programming Leadership
Lead programming activities for clinical studies and therapeutic areas
Ensure timely and high-quality delivery of programming outputs
Work across multiple global studies and stakeholders
2. Clinical Data Standards & CDISC Implementation
Develop SDTM and ADaM datasets using CDISC standards
Create mapping specifications and programming documentation
Maintain compliance with global clinical data standards
3. SAS Programming & Analysis
Develop and validate SAS programs for:
SDTM datasets
ADaM datasets
Tables, Listings, and Figures (TLFs)
Support ad hoc and post hoc statistical analyses
Contribute to automation and macro development
4. Regulatory Submission Support
Prepare regulatory submission packages including:
define.xml
aCRF
SDRG / ADRG
ARM and eCRT packages
Support submissions for FDA, EMA, PMDA, and other authorities
Work closely with cross-functional teams for submission readiness
5. Clinical Documentation & Review
Review SAP (Statistical Analysis Plan)
Participate in CRF annotation
Review TLF specifications and outputs
Ensure consistency and compliance across documentation
6. Standards & Process Development
Develop and maintain SAS macros and programming standards
Contribute to SOP development and departmental guidelines
Participate in SME (Subject Matter Expert) initiatives
7. Leadership & Mentoring
Mentor junior statisticians and programmers
Guide new hires on programming standards and processes
Provide technical leadership across teams
8. Collaboration & Project Management
Coordinate with clinical, biostatistics, regulatory, and external vendors
Ensure timely delivery of project milestones
Manage priorities and workload across multiple studies
Required Qualifications
Education
Bachelor’s degree in:
Statistics
Computer Science
Mathematics
Engineering
Life Sciences
Or related field
Experience
8+ years in clinical statistical programming
Experience in pharmaceutical, biotech, CRO, or healthcare industry
Key Technical Skills
Strong SAS programming expertise
Knowledge of R or Python (preferred)
Expertise in CDISC standards (SDTM, ADaM)
Understanding of clinical trial design and statistical concepts
Experience with regulatory submissions (NDA, ANDA, etc.)
Familiarity with ICH guidelines and global regulatory frameworks
Soft Skills
Strong analytical and problem-solving ability
Excellent communication and collaboration skills
Ability to work independently in global teams
Leadership and mentoring capability
Strong attention to detail and quality focus
Project ownership and accountability
Core Function
This role ensures accurate, compliant, and regulatory-ready statistical programming outputs that support clinical trials, submissions, and global drug development programs.
About the Company
Sun Pharmaceutical Industries Ltd is one of India’s leading global pharmaceutical companies focused on innovative and generic medicines across multiple therapeutic areas and global markets.
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Remote, India | Siliguri |Illinois :
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Japan | Saitama |Tokyo :
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