SAS Macro Developer, Manager

About the Role The SAS Macro Developer (Manager) will design, develop, and maintain enterprise-level SAS macros to automate and standardize TLF (Tables, Listings, and Figures) generation workflows. The role also supports broader SDTM and ADaM processes and acts as a subject matter expert in automation to ensure clinical data programming meets global regulatory standards. What You'll Do

• Architect, develop, and deploy complex, dynamic, and reusable SAS macros to optimize SDTM, ADaM, and TLF generation processes.
• Build automated tools for data transformation, variable derivation, and quality control (QC) checks to improve delivery timelines.
• Ensure all macro development and validation activities follow the Software Development Life Cycle (SDLC) and comply with 21 CFR Part 11 and GxP guidelines.
• Perform robust testing of macros and maintain validation documentation including User Requirement Specifications (URS), test plans, test scripts, and traceability matrices.
• Partner with statistical programmers and biostatisticians to translate complex business requirements into scalable technical solutions.
• Provide technical guidance, code reviews, and training to promote adoption of new macros and best practices.
• Provide hands-on programming support during peak regulatory submission periods and troubleshoot complex macro-related issues. What We're Looking For
• Expert-level proficiency in Base SAS, SAS/Macro, SAS/STAT, and SAS/Graph; strong knowledge of SAS environment and performance optimization 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 in a strictly regulated, SDLC-compliant environment.
• Excellent analytical, problem-solving, and communication skills; ability to work independently and 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 related quantitative field.
• Experience: 10+ years of proven experience in Clinical/Statistical Programming in the Pharmaceutical, Biotechnology, or CRO industry; at least 3+ years of dedicated hands-on experience in advanced SAS Macro development. Compensation & Benefits
• Robust benefits and opportunities to foster personal and professional growth.