Benefits

Full Job Description

Role Overview This is a senior technical leadership opportunity within global clinical development, focused on advancing automation and programming efficiency across clinical data workflows. The role combines hands-on development, technical leadership, quality oversight, mentoring, and problem-solving within a remote or hybrid environment. What You Will Do You will design and develop enterprise-level SAS macros that standardize and accelerate Tables, Listings, and Figures generation. You will also contribute to SDTM and ADaM programming while supporting broader clinical programming initiatives. Why It Might Be a Fit This role provides opportunities for technical leadership, mentoring, and exposure to complex clinical development programs. You will have the chance to work on enterprise-level clinical programming and automation initiatives with global impact and collaborate with statistical programming, biostatistics, Biometrics, and other cross-functional teams. 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.

Skills and Technologies