Lead Statistical Programmer – SAS, SDTM/ADaM Expert

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

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.