Statistical Programmer
Location: Remote / Hybrid
Department: Biometrics / Statistical Programming
Company: Sun Pharmaceutical Industries Ltd.
Employment Type: Full-Time
Job Summary
The Statistical Programmer is responsible for leading and supporting statistical programming activities across clinical development programs. The role involves developing, validating, and maintaining clinical trial datasets, statistical outputs, and regulatory submission packages in compliance with CDISC standards and global regulatory requirements.
The incumbent will collaborate with Biostatistics, Clinical Data Management, Clinical Operations, Regulatory Affairs, Medical Writing, and external service providers to deliver high-quality programming outputs that support clinical studies, regulatory submissions, and scientific decision-making.
The position requires strong expertise in SAS programming, CDISC implementation, regulatory submissions, and clinical trial data standards.
Key Responsibilities
Statistical Programming Leadership
Lead statistical programming activities across assigned therapeutic areas, compounds, or clinical development programs.
Manage programming deliverables for multiple studies and projects simultaneously.
Ensure timely delivery of high-quality programming outputs aligned with project timelines and regulatory requirements.
Serve as a subject matter expert (SME) for statistical programming processes and standards.
CDISC Standards Implementation
Develop and maintain CDISC-compliant datasets and documentation.
Create and review:
SDTM Mapping Specifications
ADaM Specifications
Dataset Metadata
Data Validation Documentation
Ensure implementation of:
CDISC SDTM Standards
ADaM Standards
TAUG Requirements
Industry Best Practices
Dataset Programming & Validation
Develop, validate, and maintain SAS programs for:
SDTM Dataset Creation
ADaM Dataset Development
Analysis Dataset Generation
Data Transformation Activities
Perform quality control and validation activities to ensure accuracy and compliance.
Support data review and analysis activities throughout the study lifecycle.
Tables, Listings & Figures (TLFs)
Develop and validate SAS programs for:
Statistical Tables
Patient Listings
Clinical Figures
Safety Outputs
Efficacy Outputs
Review and verify statistical outputs against Statistical Analysis Plans (SAPs).
Ensure consistency and quality of study reporting deliverables.
Regulatory Submission Support
Prepare programming deliverables required for global regulatory submissions.
Develop and support:
Define.xml
Annotated CRF (aCRF)
Clinical Study Data Reviewer’s Guide (cSDRG)
Analysis Data Reviewer’s Guide (ADRG)
Analysis Results Metadata (ARM)
eCTD Submission Components
Support submissions to:
FDA
EMA
PMDA
Other Global Regulatory Agencies
Respond to regulatory authority requests related to datasets and programming deliverables.
Study Documentation & Standards
Develop and maintain programming documentation following departmental SOPs and standards.
Participate in:
CRF Annotation
SAP Review
TLF Specification Development
Dataset Documentation Review
Ensure complete audit readiness and traceability of programming deliverables.
Process Improvement & Innovation
Contribute to development and enhancement of:
Programming Standards
SOPs
Macros
Automation Tools
Best Practices
Identify opportunities to improve efficiency, quality, and compliance.
Support innovation initiatives within Statistical Programming.
Cross-Functional Collaboration
Collaborate closely with:
Biostatistics
Clinical Data Management
Clinical Operations
Regulatory Affairs
Medical Writing
Pharmacovigilance
Clinical Development Teams
External CROs and Functional Service Providers
Participate in project meetings and provide programming expertise.
Communicate risks, timelines, and deliverables effectively to stakeholders.
Mentoring & Knowledge Sharing
Mentor junior programmers and new team members.
Provide technical guidance on SAS programming and CDISC implementation.
Support training initiatives and knowledge-sharing activities.
Contribute to departmental competency development programs.
Educational Qualifications
Required
Bachelor’s or Master’s Degree in:
Statistics
Mathematics
Computer Science
Life Sciences
Pharmacy
Biotechnology
Biostatistics
Related Scientific Discipline
Preferred
Advanced degree in Statistics, Biostatistics, or related field.
SAS Certification(s).
Experience Requirements
Required
Experience in Statistical Programming within the pharmaceutical, biotechnology, CRO, or clinical research industry.
Hands-on experience with:
SAS Programming
Clinical Trial Data Analysis
Regulatory Submissions
CDISC Standards
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