Principal Statistical Programmer

IQVIA

Durham, North Carolina

JOB DETAILS
SKILLS
Best Practices, Biology, Biostatistics, Clinical Data Interchange Standards Consortium (CDISC), Clinical Practices/Protocols, Clinical Research, Clinical Support, Clinical Trial, Code Reviews, Computer Programming, Computer Science, Data Management, Data Sets, Drug Development, FDA (Food and Drug Administration), Healthcare, Leadership, Mathematics, Medical Treatment, Patient Care, Regulatory Requirements, Regulatory Submissions, Risk Analysis, Statistical Programming Languages, Statistics, Technical Leadership, XML (EXtensible Markup Language)
LOCATION
Durham, North Carolina
POSTED
30+ days ago

Job Title: Principal Statistical Programmer

Start Date:Targeted for mid‑July
 

Position Summary

We are seeking a Principal Statistical Programmer to provide full end‑to‑end statistical programming support across clinical development programs. This role requires deep technical expertise, leadership, and hands‑on delivery, covering SDTM, ADaM, TLF development, and regulatory submission support. The Principal Statistical Programmer will serve as a subject matter expert, ensure high‑quality deliverables, and contribute to programming standards and best practices.

Key Responsibilities

  • Provide end‑to‑end statistical programming support for clinical studies from study setup through submission
  • Lead and perform development and validation of:
    • SDTM datasets
    • ADaM datasets
    • Tables, Listings, and Figures (TLFs)
  • Ensure all deliverables are compliant with CDISC standards and regulatory requirements
  • Support regulatory submissions (e.g., FDA, EMA), including define.xml, submission‑ready datasets, and reviewer’s guides
  • Serve as a Principal‑level programmer, providing technical leadership and guidance to other programmers as needed
  • Contribute to and help maintain programming standards, macros, and validation processes
  • Review and approve programming deliverables to ensure accuracy, consistency, and quality
  • Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams
  • Proactively identify risks and propose efficient, compliant solutions within timelines

Required Qualifications

  • Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field
  • Extensive experience as a statistical programmer, with demonstrated Principal‑level responsibilities
  • Strong hands‑on experience with:
    • SDTM and ADaM dataset development
    • TLF programming
    • Regulatory submission deliverables
  • Expert proficiency in base SAS and Advanced SAS with good hands on SAS Macros
  • In‑depth knowledge of CDISC standards, regulatory guidelines, and submission requirements
  • Proven ability to manage complex studies independently from start to finish

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $98,200.00 - $273,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

About the Company

I

IQVIA

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology and human intelligence to reimagine and deliver ways to help make them a reality. It’s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It’s about exploring a new path to better health outcomes via Human Data Science. It’s about harnessing the power of the IQVIA CORE™ to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers. Motivated by the industry we help, we’re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward.
COMPANY SIZE
10,000 employees or more
INDUSTRY
Healthcare Services
FOUNDED
1982
WEBSITE
https://www.iqvia.com/