{"schemaVersion":"jobsearcher.job.v1","id":"262c21bc6b08e476faed54be","url":"https://jobsearcher.com/jobs/262c21bc6b08e476faed54be","canonicalUrl":"https://jobsearcher.com/jobs/262c21bc6b08e476faed54be","title":"Principal Statistical Programmer in R/Python","description":"We’re seeking an experienced Statistical Programmer to lead end-to-end programming using R/Python with deep CDISC SDTM/ADaM expertise.\nKey Responsibilities\nDevelop, validate, and maintain analysis datasets (ADaM) and SDTM mappings compliant with CDISC standards and sponsor conventions.\nBuild robust, reproducible R/Python pipelines for TFLs (tables, figures, listings) and exploratory analyses; automate QC and reporting.\nAuthor and review specifications (SDTM/ADaM define.xml metadata, ADRGs, SDRGs, programming specs).\nImplement end-to-end workflow orchestration, version control (Git), CI/CD, and package management for regulated environments.\nPerform statistical programming for inferential analyses per SAP; implement estimands where applicable.\nConduct code reviews, dual programming, and rigorous validation per SOPs and 21 CFR Part 11 expectations.\nSupport eSubmission readiness (e.g., define.xml, reviewer’s guides, data conformance checks with Pinnacle 21-like workflows).\nMentor programmers, contribute to libraries/utilities, and improve standard programming practices.\nInterface with Biostats to translate SAP into executable code; troubleshoot data issues across EDC to SDTM/ADaM flow.\nCollaborate on data visualization and dashboards for study teams and interim looks.\nRequired Qualifications\n5–8+ years in clinical/biopharma statistical programming with direct ownership of SDTM and ADaM deliverables for Phase I–III studies.\nAdvanced proficiency in R and/or Python for clinical reporting:\nR: dplyr/tidyr, data.table, haven, broom, ggplot2, quarto/rmarkdown, pkg development.\nPython: pandas, numpy, statsmodels/scikit-learn (as needed), plotly/matplotlib, pyreadstat.\nDeep working knowledge of CDISC standards (SDTM, ADaM, Controlled Terminology), define.xml, ADRG/SDRG.\nPractical SAS awareness for reading/writing XPT, integrating legacy code, and interpreting SAS-based specs/logics.\nStrong Git, code review, and documentation discipline; experience with reproducible pipelines (e.g., make/targets, renv/packrat, virtualenv/poetry, containers).\nExcellent communication; ability to partner with Biostatistics and lead programming workstreams.\nEducation\nBS/MS in Statistics, Biostatistics, Computer Science, Data Science, or related field.\nApplication Question(s):\nHow many years of experience in R programming?\nWork Location: Remote","company":"Clinvia","rawCompany":"clinvia","city":"Remote","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-07-23T15:56:50.338Z","occupations":[{"code":"15-2041.00","title":"Statisticians","slug":"statisticians"},{"code":"15-2041.01","title":"Biostatisticians","slug":"biostatisticians"},{"code":"15-2051.00","title":"Data Scientists","slug":"data-scientists"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Principal Statistical Programmer in R/Python","description":"We’re seeking an experienced Statistical Programmer to lead end-to-end programming using R/Python with deep CDISC SDTM/ADaM expertise.\nKey Responsibilities\nDevelop, validate, and maintain analysis datasets (ADaM) and SDTM mappings compliant with CDISC standards and sponsor conventions.\nBuild robust, reproducible R/Python pipelines for TFLs (tables, figures, listings) and exploratory analyses; automate QC and reporting.\nAuthor and review specifications (SDTM/ADaM define.xml metadata, ADRGs, SDRGs, programming specs).\nImplement end-to-end workflow orchestration, version control (Git), CI/CD, and package management for regulated environments.\nPerform statistical programming for inferential analyses per SAP; implement estimands where applicable.\nConduct code reviews, dual programming, and rigorous validation per SOPs and 21 CFR Part 11 expectations.\nSupport eSubmission readiness (e.g., define.xml, reviewer’s guides, data conformance checks with Pinnacle 21-like workflows).\nMentor programmers, contribute to libraries/utilities, and improve standard programming practices.\nInterface with Biostats to translate SAP into executable code; troubleshoot data issues across EDC to SDTM/ADaM flow.\nCollaborate on data visualization and dashboards for study teams and interim looks.\nRequired Qualifications\n5–8+ years in clinical/biopharma statistical programming with direct ownership of SDTM and ADaM deliverables for Phase I–III studies.\nAdvanced proficiency in R and/or Python for clinical reporting:\nR: dplyr/tidyr, data.table, haven, broom, ggplot2, quarto/rmarkdown, pkg development.\nPython: pandas, numpy, statsmodels/scikit-learn (as needed), plotly/matplotlib, pyreadstat.\nDeep working knowledge of CDISC standards (SDTM, ADaM, Controlled Terminology), define.xml, ADRG/SDRG.\nPractical SAS awareness for reading/writing XPT, integrating legacy code, and interpreting SAS-based specs/logics.\nStrong Git, code review, and documentation discipline; experience with reproducible pipelines (e.g., make/targets, renv/packrat, virtualenv/poetry, containers).\nExcellent communication; ability to partner with Biostatistics and lead programming workstreams.\nEducation\nBS/MS in Statistics, Biostatistics, Computer Science, Data Science, or related field.\nApplication Question(s):\nHow many years of experience in R programming?\nWork Location: Remote","datePosted":"2026-07-23T15:56:50.338Z","dateModified":"2026-07-23T15:56:50.338Z","hiringOrganization":{"@type":"Organization","name":"Clinvia","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"262c21bc6b08e476faed54be"},"url":"https://jobsearcher.com/jobs/262c21bc6b08e476faed54be"}}