JOB DESCRIPTION
Work Schedule
Second Shift (Afternoons)
Environmental Conditions
Office
Job Description
Principal Programmer Analyst – End-to-End SDTM
Join Us as a Principal Programmer Analyst – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last five years.
As a Principal Programmer Analyst , you will serve as a Study Lead/Lead Programmer with primary responsibility for end-to-end CDISC SDTM programming and delivery across clinical studies.
You will lead SDTM activities from study start-up and specification development through mapping, programming, validation, quality review, final delivery, and regulatory submission support. This position requires extensive hands-on SDTM expertise combined with the ability to independently lead studies, manage programming deliverables, and provide technical oversight and mentoring to programming teams.
What You’ll Do
- Serve as the Study Lead/Lead Programmer and take ownership of end-to-end SDTM programming activities across clinical studies.
- Lead SDTM activities from study start-up through final delivery and submission , ensuring quality, consistency, and compliance with applicable CDISC standards.
- Review study protocols, CRFs, data specifications, and source data to determine SDTM requirements and mapping strategies.
- Develop and review SDTM specifications and mapping documentation .
- Perform and oversee source-to-SDTM mapping across clinical domains.
- Develop, maintain, and validate SDTM datasets using SAS.
- Ensure appropriate implementation of CDISC SDTM/SDTMIG standards and controlled terminology .
- Perform SDTM compliance and quality checks and resolve validation findings.
- Support preparation and quality review of submission-ready SDTM deliverables , including associated documentation.
- Provide technical oversight and conduct peer review/QC of SDTM deliverables produced by other programmers.
- Manage study programming timelines, priorities, resources, risks, and deliverables.
- Coordinate programming activities across multiple studies or programs and ensure milestones are achieved.
- Work closely with Data Management, Biostatistics, Statistical Programming, Clinical Operations, and other cross-functional teams.
- Represent programming in internal study meetings and client/sponsor discussions.
- Provide technical guidance and mentoring to junior and senior programmers.
- Identify opportunities for SDTM standardization, automation, reusable programming, and process improvement.
- Support responses to regulatory or client questions related to SDTM programming and clinical data deliverables.
- Contribute to departmental standards, SOPs, training materials, and programming best practices.
- Support technical interviews and recruitment activities when required.
Education and Experience
- Bachelor's or Master's degree in Computer Science, Statistics, Biostatistics, Mathematics , or a related field.
- 10 years of relevant clinical/statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
- Significant hands-on experience delivering end-to-end CDISC SDTM programming for clinical studies.
- Demonstrated experience as a Study Lead, Lead Programmer, SDTM Lead, or equivalent , with independent ownership of study programming activities.
- Experience supporting regulatory submission-ready clinical data deliverables .
- Equivalent combinations of relevant education, training, and directly related experience may be considered.
Required Knowledge, Skills and Experience
- Extensive hands-on experience with end-to-end SDTM programming and delivery .
- Strong knowledge of CDISC SDTM and SDTMIG standards .
- Experience with SDTM specifications, source-to-target mapping, dataset development, programming, validation, QC, and final delivery .
- Advanced SAS programming skills , including Base SAS, PROC SQL, and SAS Macros.
- Strong understanding of clinical trial data and complex clinical data structures.
- Experience identifying, investigating, and resolving SDTM validation findings.
- Good understanding of regulatory submission requirements for standardized clinical data.
- Strong knowledge of clinical trials, ICH guidelines and GCP .
- Demonstrated Study Lead/Lead Programmer experience , including management of programming deliverables, timelines, resources, quality, and risks.
- Ability to independently lead multiple studies and coordinate programming activities across multidisciplinary teams.
- Experience reviewing programming work and providing technical oversight to other programmers.
- Strong mentoring and coaching capabilities.
- Excellent problem-solving and analytical skills with strong attention to detail.
- Strong written and verbal communication skills with the ability to interact effectively with clients, sponsors, and cross-functional teams.
- Delivery- and quality-focused approach.
Key Requirements
Candidates should demonstrate all three of the following:
1. End-to-End SDTM Expertise
Hands-on ownership across the SDTM lifecycle, including study start-up, protocol/CRF review, SDTM specifications, source-to-SDTM mapping, programming, validation, QC, final delivery, and submission support .
2. 8+ Years of Relevant Experience
At least 8 years of clinical/statistical programming experience , preferably within a pharmaceutical, biotechnology, or CRO environment.
3. Study Lead Experience
Demonstrated experience as a Study Lead, Lead Programmer, or SDTM Lead , independently managing study programming activities, timelines, deliverables, quality, and programming team coordination.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team committed to scientific excellence, innovation, and delivering meaningful outcomes for clinical research.
This is an opportunity to use your end-to-end SDTM expertise and study leadership experience to drive high-quality clinical programming deliverables while providing technical leadership across complex global clinical studies.
Apply today to help us deliver tomorrow’s breakthroughs.