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SME, CDISC & eSubmission Standards

Sun Pharmaceutical Industries Ltd -
Gurugram, Haryana

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Job details

Qualifications

Bioinformatics
Computer Science
SAS
B.Sc
R
Research
Master's degree
Analysis skills
Bachelor's degree
Macros
Software development
Metadata
Communication skills
SDLC

Full job description

Title: SME, CDISC & eSubmission Standards

Date: Jun 2, 2026

Location: Gurgaon - R&D

Company: Sun Pharmaceutical Industries Ltd

Sun Pharma is looking for an experienced SAS Macro Developer to join our team. The primary responsibilities of this role will be to develop and maintain SAS macros to support our SDTM (Study Data Tabulation Model), ADAM (Analysis Data Model), and TLF (Tables, Listings, and Figures) programming efforts, which are critical components of the drug development process.

Key Responsibilities:

Design, develop, and implement reusable SAS macros to streamline SDTM, ADAM, and TLF programming workflows
Collaborate with SAS programmers, Biostats and subject matter experts to understand business requirements and translate them into efficient macro solutions
Demonstrate a strong understanding of the drug development process and the role of SDTM, ADAM, and TLF standards in regulatory submissions
Develop macros to automate and standardize SDTM programming tasks, such as data transformation, variable derivation, and metadata generation
Maintain a good working knowledge of SDTM and ADAM standards to ensure macros are aligned with industry best practices
Optimize macro performance and ensure they are scalable and maintainable
Thoroughly test macros to validate functionality and identify/resolve any issues
Document macro code, usage, and best practices for knowledge sharing
Provide training and support to other team members on leveraging the developed macros
Stay up-to-date with the latest SAS macro language features and techniques
Will occasionally need support study team in with study SDTM/ADaM and TLFs Programming

Qualifications

Education: BSc or equivalent with research experience, and/or MS (Computer Science, Bioinformatics, or Related field). Master’s Degree preferred.
Minimum 7 years of experience in SAS programming, with a strong focus on macro development in Clinical development with strong knowledge of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines
Experience in the pharmaceutical, healthcare, or life sciences industry is highly preferred
Experience with R programming is highly preferred

Required Skills:

Proficient in writing complex, dynamic SAS macros using macro language features such as macro variables, macro functions, and macro conditional logic
Demonstrated understanding of the drug development process and familiarity with CDISC SDTM, ADAM, and TLF standards
Experience in designing modular, reusable, and maintainable macro solutions for SDTM programming tasks
Knowledge of Software Development Life(SDLC) cycle process
Strong problem-solving and analytical skills to identify and resolve macro-related issues
Excellent communication skills to collaborate with cross-functional teams
Ability to work independently and as part of a team

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SME, CDISC & eSubmission Standards

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