Senior Statistical Programmer (R)

Summary

Clinical statistical programmer with hands-on SDTM, ADaM, and TLF production and validation experience in R using pharmaverse packages, supporting an end-to-end R workflow alongside existing SAS code.

Responsibilities

• Develop SDTM datasets from raw EDC data in R (sdtm.oak).
• Develop and validate ADaM datasets in R (admiral).
• Produce TLFs in R (rtables/tern) and submission-ready datasets (xportr) for clinical study reports and regulatory submissions.
• Perform independent QC/double programming of SAS and R outputs.
• Collaborate with biostatisticians and study teams on SAPs, specs, and timelines.

Requirements

• BS/MS in Statistics, Biostatistics, Mathematics, or related field.
• 5+ years of clinical statistical programming with CDISC SDTM and/or ADaM.
• 2+ years producing clinical outputs in R using pharmaverse, including. admiral for ADaM and rtables/tern (or similar TLF packages like gtsummary or Tplyr).
• R outputs produced for actual study deliverables (e.g., CSR, DSMB, or interim analyses).
• Strong R programming skills, including tidyverse, RMarkdown/Quarto, and Git/GitHub.
• SAS experience, to work alongside existing SAS code.

Preferred Qualifications

• sdtm.oak and xportr experience.
• R outputs used in a regulatory submission.

Nice to Have

• Shiny app development, including user access control (e.g., rAccess, shinymanager, Posit Connect).