Sr Programmer Analyst II

Job description

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, continu