Principal Statistical Programmer

Reposted 7 Days Ago
Be an Early Applicant
Durham, NC, USA
In-Office
98K-273K Annually
Senior level
Healthtech
The Role
The Principal Statistical Programmer provides statistical programming support across clinical development, ensuring compliance with CDISC standards and regulatory submissions, and leading high-quality programming efforts.
Summary Generated by Built In

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.
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
Bangalore, Karnataka
61,500 Employees
Year Founded: 2016

What We Do

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.

Similar Jobs

In-Office or Remote
2 Locations
1395 Employees

Cytel Logo Cytel

Principal Statistical Programmer FSP - RWD/EPI

Software • Analytics • Biotech
In-Office or Remote
3 Locations
1395 Employees
In-Office
Durham, NC, USA
61500 Employees
69K-173K Annually

Similar Companies Hiring

Camber Thumbnail
Fintech • Healthtech • Social Impact
New York, New York
90 Employees
Sailor Health Thumbnail
Healthtech • Social Impact • Telehealth
New York City, NY
20 Employees
Granted Thumbnail
Mobile • Insurance • Healthtech • Financial Services • Artificial Intelligence
New York, New York
23 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account