Clinical R Programmer (Clinical Programming)

TL;DR

Clinical R Programmer (Clinical Programming): Develop and maintain SDTM and ADaM datasets using R for clinical trials with an accent on CDISC standards, regulatory compliance, and collaboration with biostatistics and clinical data teams. Focus on designing efficient R scripts, supporting TLF generation, and ensuring quality control of clinical trial deliverables.

Location: Remote (United States)

Company

hirify.global is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies with over 28 years of experience and 4,000 professionals worldwide.

What you will do

• Develop, validate, and maintain SDTM and ADaM datasets using R following CDISC standards.
• Support TLF generation in R or SAS as needed.
• Write efficient, reproducible R scripts for clinical data analysis and reporting.
• Collaborate with statisticians, data managers, and clinical teams to understand programming requirements.
• Perform QC checks and ensure deliverables meet regulatory expectations (FDA, EMA).
• Contribute to programming workflows, documentation, and automation initiatives.

Requirements

• Location: Must be based in the United States or able to work remotely within the US
• Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
• 2–6+ years of experience in clinical programming with strong R skills.
• Proven experience creating SDTM and ADaM datasets using R and working knowledge of SAS.
• Solid understanding of CDISC standards and clinical trial regulatory compliance.
• Strong analytical, problem-solving, and documentation skills.

Nice to have

• Experience with R packages like tidyverse, haven, pharmaverse (admiral, tidyCDISC).
• Knowledge of R Markdown, Shiny apps, or reproducible reporting tools.
• Exposure to GxP validation, version control (Git), and automated workflows.
• Experience working in a CRO or pharmaceutical environment.

Culture & Benefits

• Commitment to diversity and inclusivity with a diverse workforce.
• Continuous training and development to maintain high qualifications.
• Low industry-average turnover rates indicating a stable work environment.

Hiring process

• Submit CV and receive acknowledgement.
• Phone interview as the first step if requirements are met.
• No individual replies if not successful due to volume of applications.