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).