AD Clinical Pharmacology Data Programming Specialist

Location: Princeton, New Jersey

Work Arrangement: Hybrid

Employment Type: Full-time

This international biotechnology company is dedicated to developing innovative and differentiated therapies for patients with cancer and other serious diseases. Its research and development organization combines advanced therapeutic platforms with translational, quantitative, and data sciences to support a growing global clinical portfolio.

A global, science-driven biotechnology company is seeking an Associate Director, Clinical Pharmacology Data Programming to provide technical expertise and project leadership across data programming, data management, and quality-control activities supporting clinical pharmacology and pharmacometrics.

This position combines hands-on programming with cross-functional project leadership. The successful candidate will deliver high-quality, analysis-ready datasets and quantitative outputs, establish programming and QC approaches, coordinate project timelines, and collaborate with clinical pharmacologists, pharmacometricians, Clinical Programming, Data Management, Biostatistics, Bioanalytics, Biomarkers, and external partners.

The position offers an opportunity to work at the intersection of clinical pharmacology, pharmacometrics, data science, and regulatory development within an innovative global organization.

• Lead or support the programming and quality control of analysis-ready datasets and outputs for population PK, exposure-response, PK/PD, noncompartmental analysis, modeling and simulation, immunogenicity, biomarkers, and related quantitative analyses.
• Develop, maintain, and independently QC NONMEM-ready and other pharmacometric analysis datasets.
• Integrate and pool complex clinical, dosing, PK, PD, immunogenicity, biomarker, efficacy, safety, laboratory, SDTM, ADaM, and other relevant data across studies.
• Develop and maintain programming specifications, derivation rules, analysis datasets, tables, figures, listings, and exploratory outputs.
• Provide programming support for data-driven analyses, publications, conference presentations, health-authority requests, and other clinical pharmacology deliverables.

• Perform independent QC of analysis datasets, derivations, programs, tables, figures, listings, and other quantitative outputs.
• Develop validation plans and QC strategies based on the intended use and regulatory importance of each analysis.
• Design, test, validate, and document programming logic and reusable analytical workflows.
• Ensure appropriate traceability, reproducibility, documentation, and version control.
• Develop automated and reusable data checks and QC tools to improve quality, consistency, and efficiency.

• Plan and coordinate programming activities, milestones, and deliverables across one or more development programs.
• Partner with clinical pharmacology and quantitative-sciences colleagues to define data and programming requirements.
• Proactively identify risks related to scope, data availability, timelines, and deliverables.
• Prioritize competing requests and support rapid-turnaround or ad hoc analyses when required.
• Contribute to resource planning and the development of scalable programming strategies as the clinical portfolio grows.

• Provide programming and QC support for the clinical pharmacology components of global regulatory submissions.
• Support the preparation and quality control of datasets, analyses, tables, figures, and supporting documentation for clinical pharmacology reports, Module 2.7.2, and related…