SME – CDISC & eSubmission Standards
Location: Gurugram, India
Department: Biometrics / Statistical Programming
Employment Type: Full-Time
Company: Sun Pharmaceutical Industries Ltd.
Job Summary
The SME – CDISC & eSubmission Standards is responsible for designing, developing, and maintaining advanced SAS macro solutions that support clinical data standardization, statistical programming, regulatory submissions, and automation initiatives across clinical development programs.
The role serves as a Subject Matter Expert (SME) in CDISC standards, including SDTM and ADaM, and provides technical leadership in developing scalable, reusable programming frameworks that improve efficiency, quality, and compliance of clinical trial deliverables.
The incumbent will collaborate closely with Biostatistics, Statistical Programming, Clinical Data Management, Regulatory Affairs, and Clinical Development teams to ensure high-quality regulatory-compliant submission packages and programming deliverables.
Key Responsibilities
SAS Macro Development & Automation
Design, develop, validate, and maintain reusable SAS macros to support clinical programming activities.
Create automated solutions for:
SDTM Dataset Generation
ADaM Dataset Creation
TLF (Tables, Listings, and Figures) Production
Metadata Generation
Quality Control Processes
Regulatory Submission Deliverables
Develop scalable and maintainable macro frameworks that improve programming efficiency.
Optimize macro performance for large clinical datasets and complex studies.
CDISC Standards Implementation
Serve as Subject Matter Expert (SME) for:
CDISC SDTM Standards
CDISC ADaM Standards
CDASH Concepts
Regulatory Submission Standards
Ensure all programming deliverables comply with current CDISC implementation guidelines.
Support implementation of evolving CDISC standards and regulatory requirements.
Provide technical guidance on data standardization and submission readiness.
Statistical Programming Support
Support clinical study teams with:
SDTM Programming
ADaM Development
TLF Programming
Data Validation Activities
Participate in study-specific programming activities when required.
Review programming specifications and ensure consistency with standards.
Support creation of analysis-ready datasets for statistical analyses.
Cross-Functional Collaboration
Collaborate closely with:
Biostatistics
Statistical Programming
Clinical Data Management
Clinical Development
Regulatory Affairs
Medical Writing
External CRO Partners
Translate business and study requirements into efficient programming solutions.
Participate in study team meetings and technical discussions.
Provide expertise during planning and execution of submission activities.
Regulatory Submission Support
Support preparation of datasets and documentation required for regulatory submissions.
Ensure compliance with:
FDA Requirements
EMA Requirements
PMDA Requirements
ICH Guidelines
CDISC Standards
Assist in creation and validation of submission-ready deliverables.
Support responses to regulatory agency questions related to programming outputs.
Quality Control & Validation
Develop robust testing strategies for SAS macros and automated programming tools.
Perform validation and quality review of programming deliverables.
Troubleshoot and resolve macro-related issues and programming challenges.
Ensure programming outputs meet quality, accuracy, and compliance requirements.
Documentation & Standards Management
Create and maintain:
Technical Specifications
Macro Documentation
User Guides
Programming Standards
Validation Documentation
Ensure proper version control and documentation practices.
Contribute to departmental standards and best practices.
Training & Knowledge Sharing
Provide training and mentorship to programming teams.
Conduct workshops and technical sessions on:
SAS Macro Development
CDISC Standards
Regulatory Submission Requirements
Programming Best Practices
Promote adoption of standardized programming methodologies across teams.
Innovation & Continuous Improvement
Identify opportunities for automation and process optimization.
Evaluate emerging technologies and programming methodologies.
Support development of innovative tools and frameworks to enhance programming efficiency.
Stay current with advances in:
SAS Programming
R Programming
CDISC Standards
Regulatory Submission Technologies
Educational Qualifications
Required
Bachelor’s Degree in:
Computer Science
Statistics
Mathematics
Life Sciences
Bioinformatics
Related Scientific or Technical Discipline
Preferred
Master’s Degree in:
Computer Science
Bioinformatics
Statistics
Data Science
Related Field
Experience Requirements
Required
Minimum 7 years of experience in Clinical SAS Programming.
Significant experience in SAS Macro Development within clinical research and drug development environments.
Experience supporting clinical trials and regulatory submissions.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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