Principal Clinical Data Scientist Consultant (R)

TL;DR

Principal Clinical Data Scientist Consultant (R): Developing open-source tools, R packages, and clinical datasets to power biostatistics and data management with an accent on CDISC standards and reproducible workflows. Focus on automating clinical data pipelines, ensuring regulatory submission readiness, and building internal tooling like R Shiny modules.

Location: Remote (United States)

Company

hirify.global is a global full-service CRO specializing in clinical development for pharmaceutical, biotechnology, and medical device companies.

What you will do

• Develop and maintain SDTM and ADaM datasets using R and the pharmaverse.
• Generate Tables, Listings, and Figures (TLFs) in R or SAS based on study needs.
• Perform Pinnacle21 validation and resolve findings to ensure CDISC compliance.
• Contribute to open-source and internal tooling, including R Shiny modules, R packages, and Python utilities.
• Collaborate with statisticians and data managers to translate programming requirements into deliverables.
• Ensure all outputs meet FDA and EMA regulatory expectations.

Requirements

• Must be based in the United States
• 5+ years of experience in clinical programming with a strong focus on R.
• Proven expertise in producing SDTM and ADaM datasets using admiral.
• Proficiency with Pinnacle21 validation and CDISC standards (SDTM, ADaM).
• Working knowledge of SAS and Python for analytics and scripting.
• Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, or Life Sciences.

Nice to have

• Fluency in tidyverse and experience with tidyCDISC or rtables.
• Experience building R packages or R Shiny apps.
• Exposure to AI/ML tooling in a clinical or programming context.
• Real-World Evidence (RWE) experience with claims or EHR data.
• Proficiency with Git, CI/CD, and GxP validation.

Culture & Benefits

• Opportunity to work for a single sponsor with the security of a global CRO.
• Focus on continuous training and professional development to maintain high expertise.
• Commitment to diversity, inclusivity, and equal opportunity employment.
• Stable work environment with low industry-average turnover rates.
• Flexible remote work arrangement.

Hiring process

• Initial CV screening.
• Phone interview for qualified candidates.