Sr Programmer Analyst II

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Senior Programmer Analyst – Make an Impact at the Forefront of Innovation The Senior Programmer Analyst performs advanced statistical programming activities to support clinical research projects and plays a key role in delivering high-quality, regulatory-compliant programming outputs. This role independently leads programming activities for moderately complex studies or serves as a senior programming team member on larger, more complex projects. The successful candidate will have end-to-end clinical programming experience, taking ownership of the entire study lifecycle—from protocol and SAP review through SDTM and ADaM dataset development, TLF programming, quality control, and submission-ready deliverables. In addition, the Senior Programmer Analyst provides technical guidance, mentoring, and training to junior programmers while collaborating closely with biostatisticians, data management, and cross-functional study teams. What You'll Do Lead statistical programming activities for selected clinical studies of moderate complexity, partnering directly with project leaders, biostatisticians, and client representatives to establish programming strategies, timelines, and deliverables. Independently manage end-to-end statistical programming activities throughout the clinical study lifecycle, including: Reviewing study documents such as Protocols, Statistical Analysis Plans (SAPs), CRFs, and specifications. Developing, validating, and maintaining CDISC-compliant SDTM and ADaM datasets. Programming, validating, and delivering Tables, Listings, and Figures (TLFs). Performing quality control (QC) and ensuring traceability from raw data through final outputs. Supporting regulatory submission-ready deliverables in accordance with FDA, EMA, PMDA, and other applicable standards. Develop, execute, maintain, and validate SAS programs for data integration, data transformation, reporting, and analysis across multiple data management systems and operating environments. Generate and validate datasets, reports, listings, tables, figures, and derived outputs while ensuring programming quality and compliance with company and regulatory standards. Independently manage programming assignments, priorities, and timelines while delivering high-quality work within project schedules and contractual obligations. Collaborate effectively with Biostatistics, Clinical Data Management, Medical Writing, Clinical Operations, and other cross-functional teams to ensure successful study execution. Perform programming quality control reviews and contribute to continuous process improvements and programming standards. Mentor, train, and provide technical guidance to junior programmers through code reviews, knowledge sharing, and best practices. Contribute to departmental initiatives, including SOP development, working practice documents, training materials, process improvements, and innovation projects. Support proposal development and bid defense activities by providing statistical programming input and effort estimates. Education & Experience Requirements Master's degree in computer science, Statistics, Biostatistics, Mathematics, or a related discipline with at least 5 years of relevant experience; OR Bachelor's degree in computer science, Statistics, Biostatistics, Mathematics, or a related discipline (or equivalent qualification) with at least 6 years of relevant statistical programming experience. Knowledge, Skills & Abilities Strong SAS programming experience with the ability to independently develop and validate clinical programming deliverables. Demonstrated end-to-end clinical programming experience, including SDTM, ADaM, TLF programming, validation, and regulatory submission support. Strong understanding of CDISC standards, including SDTM and ADaM. Experience performing programming QC and validation using industry best practices. Solid understanding of clinical trial processes and the statistical programming lifecycle. Strong understanding of relational databases and complex clinical data structures. Excellent analytical, problem-solving, and debugging skills. Strong written and verbal communication skills with the ability to effectively collaborate with global teams and clients. Ability to independently manage multiple studies and competing priorities. Experience mentoring junior programmers and providing technical leadership. Demonstrated initiative, accountability, and commitment to quality. Ability to adapt quickly to changing priorities and project needs. Working Conditions Work is performed primarily in an office or hybrid environment with standard office equipment. Occasional domestic and international travel may be required. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global organization dedicated to enabling customers to make the world healthier, cleaner, and safer. You'll work alongside talented professionals in a collaborative environment where innovation, continuous learning, and career growth are encouraged. Join us and help accelerate the delivery of life-changing therapies through high-quality statistical programming and scientific excellence.