Statistical Programmer (R)

Job Summary – Senior Statistical Programmer (R)

- Primarily responsible for statistical programming in R (not SAS-first).
- Direct experience supporting biotech/pharma companies (no CRO, government, or academic backgrounds).
- Oncology therapeutic area experience required.
- Hands-on end-to-end programming using R, especially pharmaverse packages, for clinical trials.
- Develop SDTM datasets from raw EDC data in R (using sdtm.oak).
- Develop and validate ADaM datasets in R (using admiral).
- Produce and validate TLFs in R (using rtables/tern or similar), and create submission-ready datasets (xportr).
- Perform independent QC and double programming of outputs from both SAS and R.
- Collaborate with biostatisticians and study teams on SAPs, specifications, and project timelines.
- Requires BS/MS in Statistics, Biostatistics, Mathematics, or related field.
- At least 5 years of clinical statistical programming with CDISC SDTM/ADaM.
- Minimum 2 years of experience producing clinical outputs in R (pharmaverse: admiral, rtables/tern, gtsummary, Tplyr, etc.).
- Must have produced R outputs for actual study deliverables (e.g., CSR, DSMB, interim analyses).
- Strong skills in R (tidyverse, RMarkdown/Quarto, Git/GitHub) and some SAS experience.
- Preferred: Experience with sdtm.oak and xportr, and R outputs used in regulatory submissions.
- Nice to have: Experience with Shiny app development and user access controls (e.g., rAccess, shinymanager, Posit Connect).