Associate Principal Statistical Programmer, PKPD

IQVIA Argentina; Durham (NC); On-site; USD 88,000 - 221,000; Full time

Job summary

IQVIA in Durham, NC seeks an experienced Lead Programmer to drive SAS-based statistical programming for early-phase and regulatory submissions. You will develop CDISC SDTM/ADaM datasets and TLFs, lead dataset creation for safety, PK, and PK/PD analyses, and help shape POPPK/popPD/ER workflows within an FSP setting.

The role requires 8+ years in pharma/CRO programming, strong leadership, and proven track record supporting regulatory filings.

Qualifications

• 8+ years of statistical programming in pharma/CRO.
• Experience as Lead Programmer or technical lead.
• FSP engagement experience preferred.
• Experience supporting regulatory submissions.
• Strong communication and stakeholder management.
• Ability to work independently while managing multiple priorities.
• Experience supporting Translational Medicine or Clinical Pharmacology groups.

Responsibilities

• Lead statistical programming activities for CDISC SDTM/ADaM datasets and TLFs.
• Develop safety, PK, and PK/PD ADaM datasets.
• Support POPPK/popPD/ER dataset creation workflows and regulatory submissions.
• Collaborate with cross-functional teams in early-phase trials (I/First‑in‑Human; crossover; exposure–response).

Skills

SAS programming

CDISC SDTM/ADaM/TLFs

ADaM datasets (safety PK PK/PD)

POPPK/popPD/ER datasets

early-phase trials (I, crossover, ER)

Regulatory submissions

Lead Programmer / technical lead

FSP engagement

Communication & stakeholder mgmt

Independent work / time management

Translational Medicine exposure

Job description

Required Skills & Experience

Technical Skills

• Expert‑level SAS programming skills.
• Strong, hands‑on experience with CDISC SDTM, ADaM and TLFs.
• Proven experience developing safety, PK, and PK/PD ADaM datasets.
• Experience supporting POPPK/popPD/Exposure Response(ER) dataset creation workflows.
• Solid understanding of early‑phase clinical trial designs, including:
  • Phase I / First‑in‑Human
  • Crossover studies
  • Exposure–response analysis
  • PK parameter pooling

Experience

• 8+ years of statistical programming experience in the pharmaceutical or CRO environment.
• Demonstrated experience as a Lead Programmer or technical lead.
• Prior experience working in an FSP engagement model preferred.
• Experience supporting regulatory submissions is required.

Soft Skills

• Strong communication and stakeholder management skills.
• Ability to work independently while managing multiple priorities.
• Detail‑oriented with a strong commitment to quality and timelines.

Preferred Qualifications

• Experience supporting Translational Medicine or Clinical Pharmacology groups.
• Familiarity with internal exploratory analysis and early‑phase decision‑making needs.
• Exposure to integrated summaries or pooled PK analyses across studies.

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 $88,300.00 - $220,900.00. 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.