Principal Statistical Programmer

IQVIA
Location
Durham, North Carolina, United States of America
Job Type
Full-time
Posted
November 11, 2026
Salary Range
$98k - $273k USD

Job Description

Job Title: Principal Statistical Programmer

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.

Frequently Asked Questions

Where is this job located, and is it remote, hybrid, or on-site?
The role is located in Durham, North Carolina, United States of America. The posting does not specify whether the position is remote, hybrid, or on-site.
What qualifications do I need for this role?
You need a Bachelor's or Master's in Statistics, Mathematics, Computer Science, Life Sciences, or a related field. You also need extensive statistical programming experience at Principal level, strong SDTM/ADaM and TLF experience, regulatory submission experience, expert Base and Advanced SAS with SAS Macros, in-depth CDISC knowledge, and the ability to manage complex studies independently.
What are the main responsibilities of the position?
You will provide end-to-end statistical programming from study setup through submission. This includes leading development and validation of SDTM and ADaM datasets and TLFs, and supporting FDA/EMA submissions (define.xml, reviewer's guides). You will also guide other programmers, maintain standards and macros, and review and approve deliverables.
What is the salary range?
The potential annualized base pay range is $98,200 to $273,200. Actual pay depends on qualifications, skills, education, experience, location, and schedule. Incentive plans, bonuses, or other compensation may be offered depending on the position.
What benefits are offered?
The posting states that a range of health and welfare and/or other benefits may be offered, depending on the position. Specific benefits are not detailed.
Which teams will I work with?
You will collaborate closely with the Biostatistics, Data Management, Clinical Operations, and Regulatory teams. You will also provide technical leadership and guidance to other programmers as needed.

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Job Information

Source: manual
AI Relevance: 88/100 (Highly relevant)
Remote Type: onsite
Skills & Tags:
iqvia biostatistics clinical
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