Principal Data Scientist Consultant (R, CDISC)

TL;DR

Principal Data Scientist Consultant (R/CDISC): Developing and validating SDTM and ADaM datasets for clinical trials with an accent on regulatory compliance and high-quality data reporting. Focus on building reproducible R scripts, supporting clinical deliverables, and collaborating with biostatistics teams to ensure adherence to CDISC standards.

Location: Must be based in the 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.

What you will do

• Develop, validate, and maintain SDTM and ADaM datasets using R following CDISC standards.
• Support the generation of Tables, Listings, and Figures (TLF) using R or SAS.
• Write efficient, reproducible, and well-structured R scripts for clinical data analysis.
• Collaborate with statisticians, data managers, and clinical teams to meet programming requirements.
• Perform QC checks and reconcile data issues to ensure deliverables meet FDA and EMA regulatory expectations.
• Contribute to programming workflows, documentation, and version control best practices.

Requirements

• Must be based in the United States.
• Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, or Life Sciences.
• 4–6+ years of experience in clinical programming with a strong focus on R.
• Proven experience in creating SDTM and ADaM datasets using R.
• Solid understanding of CDISC standards and regulatory submission processes.
• Working knowledge of SAS programming.

Nice to have

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

Culture & Benefits

• Opportunity to work directly for a single sponsor while maintaining the security of a global CRO.
• Commitment to continuous training and professional development.
• Focus on diversity, inclusivity, and equal opportunity employment.
• Low industry-average turnover rates reflecting a supportive work environment.

Hiring process

• Submission of CV for review.
• Phone interview for qualified candidates.