Principal Statistical Programmer, PKPD

Responsibilities

• Develop safety, PK, and PK/PD ADaM datasets for early-phase clinical trials
• Support POPPK, popPD, and Exposure Response (ER) dataset creation workflows
• Act as a Lead Programmer or technical lead on clinical programming projects
• Apply expertise in early-phase clinical trial designs, including Phase I, First-in-Human, and crossover studies
• Manage stakeholder communications and multiple priorities while ensuring high-quality deliverables and adherence to timelines

Requirements

• 8+ years of statistical programming experience within a pharmaceutical or CRO environment
• Expert-level SAS programming skills
• Strong, hands-on experience with CDISC SDTM, ADaM, and TLFs
• Proven experience in PK and PK/PD ADaM dataset development
• Experience supporting regulatory submissions
• Demonstrated experience in a Lead Programmer or technical leadership capacity

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 multiple studies
• Prior experience working in an FSP engagement model

About the Company

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.