TL;DR

Senior PK/PD Programmer/Analyst (Clinical Trials): Developing and validating PK/PD analysis datasets and generating TLFs to support clinical development programs with an accent on regulatory compliance and data quality. Focus on modeling support, programming expertise in SAS and R, and ensuring high-quality deliverables for regulatory submissions.

Location: Onsite at Upper Gwynedd, PA

Company

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies, with over 4,000 professionals in more than 20 countries.

What you will do

  • Develop and validate PK/PD analysis datasets (ADaM, SDTM as applicable) for clinical development programs.
  • Generate Tables, Listings, and Figures (TLFs) for PK/PD studies and regulatory submissions.
  • Support population PK, exposure-response, and other modeling analyses for pharmacometricians.
  • Perform data cleaning, reconciliation, QC, and validation of programming outputs.
  • Ensure compliance with CDISC standards (SDTM, ADaM) and support regulatory submissions (IND, NDA, BLA).
  • Collaborate with Clinical Pharmacology, Biostatistics, Data Management, and Medical Writing teams.

Requirements

  • 5–8+ years of programming experience in clinical trials.
  • 3+ years of PK/PD programming experience.
  • Experience with NMPKPD and ER datasets.
  • Working knowledge of NONMEM, Monolix, Phoenix WinNonlin, or similar modeling tools.
  • Experience with CDISC standards (SDTM, ADaM).
  • Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field.

Nice to have

  • Experience with R programming.
  • Experience in Early-Stage Development studies.

Culture & Benefits

  • Work for a global CRO with strong focus on quality and professional development.
  • Opportunity to work directly for a single sponsor client.
  • Supportive culture with continuous training and development for employees.
  • Diverse and inclusive environment, valuing talent from various backgrounds.
  • Below industry average turnover rates.