Associate Principal Statistical Programmer, PKPD
$88,300–$220,900 year
On-siteDurham, North Carolina, United States
Durham, North Carolina, United StatesOn-siteFull Time$88,300–$220,900 yearSenior LevelEnterprise
Full TimeSenior LevelEnterprise
Job Summary
Develop safety, PK, and PK/PD ADaM datasets using expert-level SAS programming and CDISC standards (SDTM, ADaM, TLFs). Support POPPK/popPD/Exposure Response dataset creation workflows and early-phase clinical trial designs, including Phase I/First-in-Human Crossover studies and exposure–response analysis. Lead technical efforts for PK parameter pooling and regulatory submissions within an FSP engagement model. Manage multiple priorities independently while ensuring quality and timelines for translational medicine or clinical pharmacology groups.
Required Qualifications
- 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
- 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
- Strong communication and stakeholder management skills
- Ability to work independently while managing multiple priorities
- Detail‐oriented with a strong commitment to quality and timelines
Desired 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
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