Remote Senior Statistical Programmer: R SDTM/ADaM Expert

SimulStat Incorporated; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

SimulStat Incorporated in the United States seeks a Senior Statistical Programmer (R) to lead end-to-end data programming for regulatory submissions. You will work on SDTM/ADaM in R with pharmaverse packages, supporting an efficient, compliant workflow alongside SAS code.

Responsibilities include creating SDTM/ADaM datasets, producing TLFs, and delivering submission-ready datasets for CSR, DSMB, or interim analyses. Collaboration with biostatisticians and study teams is essential.

Qualifications

• 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 (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

R programming

tidyverse

RMarkdown/Quarto

Git/GitHub

SAS

SDTM/ADaM

TLF production

Education

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

Tools

sdtm.oak

xportr

admiral

rtables

tern

gtsummary

Tplyr

Job description

SimulStat Incorporated in the United States seeks a Senior Statistical Programmer (R) to lead end-to-end data programming for regulatory submissions. You will work on SDTM/ADaM in R with pharmaverse packages, supporting an efficient, compliant workflow alongside SAS code.

Responsibilities include creating SDTM/ADaM datasets, producing TLFs, and delivering submission-ready datasets for CSR, DSMB, or interim analyses. Collaboration with biostatisticians and study teams is essential.