SAS Macro Developer, Manager

Title

Manager, SAS Macro Developer

Global Clinical Development

Manager

Remote/Hybrid

This position focuses on designing, developing, and maintaining enterprise-level SAS macros, primarily to automate and standardize TLF generation workflows. The incumbent will also support broader SDTM and ADaM processes, ensuring clinical data programming meets global regulatory standards.

• 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 macro development and validation activities rigorously follow the SDLC and comply with 21 CFR Part 11 and GxP guidelines.
• Perform robust testing of macros and maintain comprehensive validation documentation including 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 review, and training to the broader Biometrics team to promote adoption of new macros and programming best practices.
• Offer programming support during peak regulatory submission periods and troubleshoot complex macro-related issues.

• Expert-level proficiency in Base SAS, SAS/Macro, SAS/STAT, and SAS/Graph; strong understanding of SAS environment and performance optimization.
• 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 an SDLC-compliant environment.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and lead technical initiatives in a global matrix environment.

Minimum Masters or Bachelor's degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related quantitative field.

10+ years of proven experience in Clinical/Statistical Programming within the pharmaceutical, biotechnology, or CRO industry, with at least 3+ years of dedicated hands‑on SAS Macro development.

Sun Pharma provides robust benefits and opportunities to foster personal and professional growth.

The preceding job description has been designed to indicate the general nature and level of work performed by employees 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).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectionate or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.