Senior Statistical Programmer — R SDTM/ADaM for Submissions

Katalyst-Healthcares-; Port Reading (NJ); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst-Healthcares is seeking a Clinical Statistical Programmer to drive SDTM/ADaM development from raw EDC data using R and pharmaverse packages. You will build end-to-end workflows alongside SAS code and contribute to regulatory submission-ready outputs.

Responsibilities include QC/double programming, collaboration with biostatistics on SAPs and timelines, and delivering CSR-urgent deliverables with R, xportr, and RMarkdown tooling.

Qualifications

• 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.
• 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.

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.

Skills

CDISC SDTM/ADaM

R programming

SAS programming

Data QC

Team collaboration

Education

BS/MS in Statistics, Biostatistics, Mathematics, or related field

Tools

pharmaverse packages (admiral)

xportr

rtables/tern

gtsummary

Tplyr

tidyverse

RMarkdown/Quarto

Git/GitHub

Job description

Katalyst-Healthcares is seeking a Clinical Statistical Programmer to drive SDTM/ADaM development from raw EDC data using R and pharmaverse packages. You will build end-to-end workflows alongside SAS code and contribute to regulatory submission-ready outputs.

Responsibilities include QC/double programming, collaboration with biostatistics on SAPs and timelines, and delivering CSR-urgent deliverables with R, xportr, and RMarkdown tooling.