Sr. Clinical Developer/ SME (R+Clinical)

Hi,

Job Details

• Position: Senior Clinical Developer/SME (R + Clinical)
• Location: Anywhere on the U.S. East Coast
• Experience Required: 8+ years of deep R programming experience
• Primary Skills: R, Pharmacokinetics (PK/PD), Clinical Data Processing, CDISC SDTM/ADaM
• Key Technologies: R Shiny, tidyverse, data.table, PKNCA, mrgsolve, rxode2
• Clinical Modeling Tools: NONMEM, Monolix, Phoenix WinNonlin
• Reporting Tools: R Markdown, Quarto
• Work Arrangement: Hybrid

Role Overview

We are seeking an experienced Senior Clinical Developer/SME with strong R programming and pharmacometrics expertise to develop and maintain reproducible clinical data processing workflows, analytical tools, and interactive dashboards.

The role focuses on transforming raw clinical trial data into analysis-ready datasets for Non-Compartmental Analysis (NCA) and population pharmacokinetic (PK) modeling. The ideal candidate will have extensive experience with R-based software development, pharmacokinetic data analysis, CDISC standards, and integration with clinical modeling software.

The selected candidate will collaborate closely with pharmacometricians and clinical teams to improve data processing, analytical workflows, reporting, and reproducibility.

Key Responsibilities

• Design, develop, and maintain robust, reproducible R-based pipelines to process raw clinical data into analysis-ready datasets.
• Prepare pharmacokinetic datasets, including CDISC PC (Pharmacokinetic Concentrations) and PP (Pharmacokinetic Parameters) domains, for NCA and population PK modeling.
• Develop and maintain internal R packages for PK/PD analysis, ensuring code quality through unit testing, documentation, and version control.
• Build and deploy interactive R Shiny dashboards for clinical data exploration, dose-escalation monitoring, and safety-efficacy visualization.
• Collaborate with pharmacometricians to optimize data transfers between R and modeling software such as NONMEM and Monolix.
• Support post-processing of modeling outputs and ensure data consistency throughout analytical workflows.
• Apply statistical programming best practices using tidyverse, data.table, and object-oriented programming approaches.
• Develop reproducible clinical reports using R Markdown or Quarto.
• Maintain reliable, documented, and version-controlled analytical workflows.
• Support clinical reporting and regulatory submission activities, including Tables, Listings, Figures (TLFs), and Clinical Study Report (CSR) sections, where applicable.
• Contribute to code reviews, technical documentation, and continuous improvement of R-based analytical solutions.

Required Skills & Qualifications

1. Advanced R Programming

• 8+ years of deep hands-on experience with R.
• Strong knowledge of tidyverse and data.table.
• Experience with object-oriented programming in R, including S3, S4, and R6.
• Ability to develop maintainable, reusable, and reproducible analytical workflows.

2. Pharmacokinetics & Pharmacometrics

• Strong understanding of pharmacokinetic and pharmacodynamic (PK/PD) concepts.
• Knowledge of parameters such as Cmax, AUC, clearance, and volume of distribution.
• Experience processing clinical trial data for pharmacokinetic analysis.
• Familiarity with PK-specific R packages such as mrgsolve, rxode2, PKNCA, or nca.

3. Clinical Data Standards

• Proficiency in CDISC standards, particularly SDTM and ADaM.
• Specific experience with PC and PP domains.
• Ability to prepare clinical datasets for NCA and population PK modeling.

4. Clinical Modeling Integration

• Experience preparing data for NONMEM, NLME, or Phoenix WinNonlin.
• Ability to support data exchange between R-based workflows and pharmacometric modeling tools.
• Experience with post-processing modeling outputs is valuable.

5. R Package Development & Interactive Analytics

• Experience developing internal R packages.
• Knowledge of unit testing, Roxygen2 documentation, and Git version control.
• Experience building interactive dashboards using R Shiny.

6. Reproducible Reporting

• Strong experience with R Markdown or Quarto for automated clinical reporting.
• Ability to generate consistent, reproducible, and well-documented analytical outputs.

Preferred Qualifications

• Experience preparing Tables, Listings, and Figures (TLFs) and Clinical Study Report (CSR) sections.
• Knowledge of FDA, EMA, and PMDA regulatory submission expectations.
• Experience mentoring junior programmers and data scientists in R programming and PK data handling.
• Advanced Git workflows, including branching and pull request reviews.
• Experience with CI/CD pipelines for R package validation.
• Familiarity with GxP, ICH-Google Cloud Platform, and 21 CFR Part 11 requirements for computer system validation.
• Awareness of First-in-Human (FIH), Multiple Ascending Dose (MAD), Single Ascending Dose (SAD), and Drug-Drug Interaction (DDI) study designs.