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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.