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Hours Full-time, Part-time
Location Avenel, NJ 07001
Avenel, New Jersey open_in_new

About this job

Job Description

Job Description
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).

Nearby locations

Posting ID: 1310092559 Posted: 2026-10-29 Job Title: Senior Statistical Programmer R