At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
JOB DESCRIPTION:
The SAS Macro Developer (Manager) will be instrumental in designing, developing, and maintaining enterprise-level SAS macros, with a primary focus on automating and standardizing TLF (Tables, Listings, and Figures) generation workflows. While the core expertise will drive TLF efficiencies, the incumbent will also support broader SDTM and ADaM processes. The incumbent will serve as a subject matter expert in automation and play a critical role in ensuring clinical data programming meets global regulatory standards.
In this role, a typical day might include the following:
Architect, develop, and deploy complex, dynamic, and reusable SAS macros to optimize SDTM, ADaM, and TLF generation processes.
Build automated tools and utilities for data transformation, variable derivation, and quality control (QC) checks to improve delivery timelines.
Ensure all macro development and validation activities rigorously follow the Software Development Life Cycle (SDLC) and comply with 21 CFR Part 11 and GxP guidelines.
Perform robust testing of macros. Author and maintain comprehensive validation documentation including User Requirement Specifications (URS), test plans, test scripts, and traceability matrices.
Partner with statistical programmers, biostatisticians to translate complex business requirements into scalable technical solutions.
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Provide technical guidance, code review, and training to the broader Biometrics team to promote the adoption of new macros and programming best practices.
Provide hands-on programming support during peak regulatory submission periods and troubleshoot complex macro-related issues.
This Role May Be For You If Have:
Expert-level proficiency in Base SAS, SAS/Macro, SAS/STAT, and SAS/Graph. Strong understanding of SAS environment and performance optimization techniques for large clinical datasets.
In-depth knowledge of clinical drug development phases and CDISC standards (SDTM, ADaM, Define.xml).
Deep understanding of regulatory submission requirements (FDA, EMA) and experience working in a strictly regulated, SDLC-compliant environment.
Excellent analytical, problem-solving, and communication skills. Ability to work independently as well as lead technical initiatives in a global matrix environment.
Educational Qualification: Minimum Master’s or Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related quantitative field.
Experience: 10+ years of proven experience in Clinical/Statistical Programming within the Pharmaceutical, Biotechnology, or CRO industry. At least 3+ years of dedicated hands-on experience in advanced SAS Macro development.
Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
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