SME CDISC And ESubmission Standards

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
  
  

• 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
  
  

• 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