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).