This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a SAS Macro Developer, Manager based in India.
This is a senior technical leadership opportunity within global clinical development, focused on advancing automation and programming efficiency across clinical data workflows.
You will design and develop enterprise-level SAS macros that standardize and accelerate Tables, Listings, and Figures generation.
The role also provides opportunities to contribute to SDTM and ADaM programming while supporting broader clinical programming initiatives.
You will act as a subject matter expert in SAS automation, helping teams adopt scalable solutions and programming best practices.
Your work will directly support high-quality clinical data deliverables and regulatory submissions in a highly controlled environment.
You will collaborate with statistical programmers, biostatisticians, and global cross-functional teams to transform complex requirements into robust technical solutions.
This role combines hands-on development, technical leadership, quality oversight, mentoring, and problem-solving within a remote or hybrid environment.
Accountabilities:
- Architect, develop, test, deploy, and maintain complex, dynamic, and reusable SAS macros designed to automate and standardize TLF generation workflows.
- Develop scalable SAS tools and utilities supporting SDTM, ADaM, and TLF processes, including data transformation, variable derivation, and automated quality-control checks.
- Optimize SAS programs and macro solutions for performance, reliability, maintainability, and efficient processing of large clinical datasets.
- Ensure macro development, testing, validation, and documentation follow established Software Development Life Cycle (SDLC) processes and applicable GxP and 21 CFR Part 11 requirements.
- Design and execute robust testing strategies and maintain comprehensive validation documentation, including User Requirement Specifications, test plans, test scripts, and traceability matrices.
- Partner with statistical programmers, biostatisticians, and other stakeholders to understand complex requirements and translate them into scalable, reusable technical solutions.
- Provide technical leadership through code reviews, programming guidance, troubleshooting, and best-practice recommendations across the Biometrics organization.
- Train and mentor team members on SAS macro development, automation approaches, programming standards, and quality practices.
- Provide hands-on programming and technical support during critical delivery periods, including regulatory submission activities.
- Investigate and resolve complex macro and programming issues while identifying opportunities for continuous automation and process improvement.
- Contribute to the adoption and standardization of automation solutions across global clinical programming activities.
Requirements:
- Bachelor’s or Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, or another relevant quantitative discipline.
- 10+ years of experience in clinical or statistical programming within the pharmaceutical, biotechnology, or CRO industry.
- At least 3+ years of dedicated, hands-on experience developing advanced SAS macros in complex clinical programming environments.
- Expert-level proficiency in Base SAS, SAS/Macro, SAS/STAT, and SAS/Graph.
- Strong understanding of SAS environments, programming architecture, and performance optimization techniques for large clinical datasets.
- In-depth knowledge of clinical drug development processes and CDISC standards, including SDTM, ADaM, and Define.xml.
- Strong understanding of regulatory submission requirements and experience working within FDA and EMA-regulated environments.
- Proven experience working within formal SDLC, GxP, and 21 CFR Part 11-compliant processes.
- Strong expertise in software validation, testing, documentation, quality control, and traceability.
- Excellent analytical and problem-solving abilities, with a structured approach to designing reliable and scalable automation solutions.
- Strong communication and collaboration skills, with the ability to work effectively with statistical programmers, biostatisticians, and global stakeholders.
- Ability to work independently, take ownership of technical initiatives, and provide leadership in a global matrix environment.
- Demonstrated ability to mentor others, conduct effective code reviews, and promote programming standards and best practices.
Benefits:
- Remote or hybrid working environment in India.
- Opportunity to work on enterprise-level clinical programming and automation initiatives with global impact.
- High-visibility technical leadership role focused on SAS automation and TLF generation.
- Exposure to SDTM, ADaM, TLF workflows, CDISC standards, and global regulatory submission requirements.
- Opportunities to collaborate with statistical programming, biostatistics, Biometrics, and other cross-functional teams.
- Scope to lead technical initiatives and influence programming standards, automation strategy, and best practices.
- Opportunities for professional growth through technical leadership, mentoring, and exposure to complex clinical development programs.
- Supportive environment focused on continuous learning, collaboration, innovation, and professional development.
- Comprehensive benefits package and programs designed to support employee well-being and career growth, subject to applicable local policies.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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