6h ago
Senior PKPD Programmer/Analyst Consultant
Upper Gwynedd, PA
seniorPharmaceutical / Clinical Research
Tech Stack
Description
As a Senior PK/PD Programmer Consultant, you will support pharmacokinetic and pharmacodynamic analyses by creating analysis datasets, generating tables/listings/figures, and ensuring high-quality deliverables for regulatory submissions in a client-facing role.
Requirements
- Strong programming expertise in SAS and/or R
- Experience with NONMEM or other modeling tools
- Solid understanding of clinical pharmacology
- Experience in PK/PD analysis for clinical development programs
- Client-facing experience with ability to work independently
Responsibilities
- Develop and validate PK/PD analysis datasets (ADaM, SDTM as applicable)
- Generate Tables, Listings, and Figures (TLFs) for PK/PD studies
- Support population PK, exposure-response, and other modeling analyses
- Perform data cleaning and reconciliation between clinical and PK datasets
- Ensure compliance with CDISC standards (SDTM, ADaM)
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