Senior Statistical Programmer (R) Katalyst Healthcares & Life Sciences - 4.0 Avenel, NJ Job Details Contract 8 hours ago Qualifications Clinical research

SAS R SAS

language Clinical program data analysis CDISC standards Clinical data analysis

Full 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).