Principal Statistical Programmer, PKPD
$98,200–$273,200 year
On-site · Durham, North Carolina, United States
Job Summary
Lead statistical programming role focusing on PK/PD with expert SAS, SDTM/ADaM, and PK/PD dataset development. Develop safety, PK and PK/PD ADaM datasets and TLFs; support POPPK/popPD/Exposure-Response workflows; apply knowledge of early-phase trial designs including Phase I/FIH and crossover studies; perform PK parameter pooling; contribute to regulatory submissions. Requires 8+ years in pharmaceutical or CRO environments with experience as a Lead Programmer or technical lead, and preferred experience in FSP engagements. Strong communication and ability to work independently while managing multiple priorities; detail-oriented with a commitment to quality and timelines.
Required Qualifications
- 8+ years of statistical programming experience in the pharmaceutical or CRO environment
- Expert-level SAS programming skills
- Strong experience with CDISC SDTM and ADaM
- Experience creating PK/PD ADaM datasets and TLFs
- Experience supporting POPPK/popPD/Exposure-Response dataset creation workflows
- Understanding of early-phase clinical trial designs (Phase I / FIH, crossover)
- Experience supporting regulatory submissions
- Strong communication and stakeholder management skills
- Ability to work independently and manage multiple priorities
- Detail-oriented with commitment to quality and timelines
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