02 Aug
|
Thermo Fisher Scientific
|
Bengaluru
02 Aug
Thermo Fisher Scientific
Bengaluru
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Senior Programmer Analyst – Make an Impact at the Forefront of InnovationThe 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 growth opportunities are encouraged.Join us and help accelerate the delivery of life-changing therapies through high-quality statistical programming and scientific excellence.
📌 Sr Programmer Analyst II (Bengaluru)
🏢 Thermo Fisher Scientific
📍 Bengaluru