PK/PD Statistical Programmer (m/w/d) - homebased

Location: Home-based in Frankfurt, Hesse, Germany

Employment: Full time

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Program, validate, and deliver NONMEM-ready PK/PD datasets based on SDTM and ADaM standards.
• Create datasets from early unclean clinical data through pre-lock and post-lock stages.
• Review data for inconsistencies and gaps, propose solutions, and improve programming efficiency.
• Perform quality control of NONMEM datasets, including deliverables from external partners.
• QC customized R packages and develop or enhance automated test suites for pharmacometrics workflows.
• Support regulatory submission deliverables and collaborate with Data Management, Biostatistics, Statistical Programming, and Bioanalytical teams.

Requirements

• Bachelor’s or Master’s degree in health, science, IT, mathematics, or a related field.
• At least 6 years of industry experience in clinical data analysis, statistical programming, or pharmacometrics support.
• Expert-level proficiency in R for data processing, dataset creation, and QC automation.
• Hands-on experience creating complex NONMEM datasets for PK/PD analyses.
• Strong knowledge of SDTM, ADaM, controlled terminology, PK/PD principles, and clinical trial concepts.
• Strong analytical, documentation, communication, and cross-functional collaboration skills.

Nice to have

• Experience standardizing NONMEM dataset creation, submission packages, and QC workflows.
• Experience with R package testing, validation frameworks, or reproducible programming practices.
• Familiarity with pharmacometrics workflows in clinical or real-world settings.

Culture & Benefits

• Home-based work arrangement.
• Collaboration across global, cross-functional teams.
• Work governed by Pharmacometrics guidelines, SOPs, working instructions, and regulatory standards.
• Focus on integrity and inspection readiness.