Senior PKPD Programmer/Analyst Consultant -Onsite at Upper Gwynedd, PA
About The Position
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Senior PK/PD Programmer Consultant to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Job Summary We are seeking an experienced Senior PK/PD Programmer to support pharmacokinetic (PK) and pharmacodynamic (PD) analyses across clinical development programs. This role is responsible for creating analysis datasets, generating tables/listings/figures (TLFs), supporting modeling activities, and ensuring high-quality deliverables for regulatory submissions. The ideal candidate has strong programming expertise (SAS and/or R), experience with NONMEM or other modeling tools, and a solid understanding of clinical pharmacology.
Requirements
- 5–8+ years of programming experience in clinical trials.
- 3+ years of PK/PD programming experience.
- Experience with NMPKPD and ER datasets.
- Experience in Early-Stage Development studies.
- Experience with CDISC standards (SDTM, ADaM).
- Strong data manipulation and visualization skills.
- Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field.
Nice To Haves
- Experience with R programming preferred.
- Working knowledge of NONMEM, Monolix, Phoenix WinNonlin, or similar tools.
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).
- Support pharmacometricians in NONMEM, Monolix, or similar modeling platforms.
- Prepare analysis-ready datasets for modeling.
- Assist with model diagnostics, simulations, and reporting outputs.
- Create graphical outputs for clinical study reports and regulatory submissions.
- Perform QC and validation of programming outputs.
- Support regulatory submissions (IND, NDA, BLA, etc.).
- Maintain documentation for programming activities.
- Work closely with Clinical Pharmacology, Biostatistics, Data Management, and Medical Writing teams.
- Participate in study team meetings and provide programming input.
- Mentor junior programmers when needed.
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What This Job Offers
Career Level
Mid Level
