Principal Statistical Programmer

L6

iqvia argentinaDurham, NCyesterday

$98,200 per year

Position Summary: We are seeking aPrincipal Statistical Programmerto providefull end‑to‑end statistical programming supportacross clinical development programs. This role requires deep technical expertise, leadership, and hands‑on delivery, coveringSDTM, 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: Provideend‑to‑end statistical programming supportfor clinical studies from study setup through submission Lead and perform development and validation of: SDTM datasetsADaM datasets Tables, Listings, and Figures (TLFs)Ensure all deliverables are compliant withCDISC standardsand regulatory requirements Supportregulatory submissions(e.g., FDA, EMA), including define.xml, submission‑ready datasets, and reviewer’s guides Serve as aPrincipal‑level programmer, providing technical leadership and guidance to other programmers as needed Contribute to and help maintainprogramming 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 astatistical programmer, with demonstrated Principal‑level responsibilities Strong hands‑on experience with: SDTM and ADaMdataset developmentTLF programming Regulatory submission deliverables Expert proficiency in base SASand Advanced SAS with good hands on SAS Macros In‑depth knowledge ofCDISC standards, regulatory guidelines, and submission requirements Proven ability to manage complex studies independently from start to finishIQVIA 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.
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Level

LeadL6

Salary

$98,200 per year

Location

Durham, NC

Occupation

Biostatisticians

Industry

Research and Development in Biotechnology (except Nanobiotechnology)

Posted

yesterday

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