{"schemaVersion":"jobsearcher.job.v1","id":"ea273ba649d18316555596cb","url":"https://jobsearcher.com/jobs/ea273ba649d18316555596cb","canonicalUrl":"https://jobsearcher.com/jobs/ea273ba649d18316555596cb","title":"Lead Statistical Programmer","description":"ALSINOVA is actively hiring a Lead Statistical Programmer for a fully remote opportunity in US. You will work on programming activities across Phase I–III HIV & Immunology programs in a fast-paced environment, working closely with Biostatistics and Data Management teams.ResponsibilitiesLead end-to-end SDTM/ADaM dataset programming and validation across HIV study teamsServe as lead programmer, overseeing timelines, deliverables, and programming risk across multiple studiesDevelop and validate TLFs (tables, listings, figures) for CSRs, ISS/ISE, and interim analysesEnsure full CDISC compliance (SDTM, ADaM, Define.xml, ADRG/cSDRG) and Pinnacle 21 validationAuthor and review programming specifications, mock shells, and derivations aligned with the SAPSupport regulatory submissions (FDA/EMA), including IND/NDA/BLA deliverablesCollaborate cross-functionally with Biostatistics, Data Management, Clinical, and Regulatory teams to resolve submission-impacting issuesMentor and provide technical leadership to junior and mid-level programmersEstablish and maintain programming standards, SOPs, and QC processesRequirements8+ years SAS/R programming in clinical trials, including prior lead programmer experienceDemonstrated experience on HIV clinical trial programs preferredR proficiency mandatory (e.g., dplyr, tidyverse, ggplot2, R Shiny)Strong expertise in CDISC standards (SDTM, ADaM, Define.xml)Regulatory submission experience (FDA/EMA) requiredPhase I–III experience; infectious disease/virology background strongly preferredProven ability to lead and mentor programming teams","company":"Astek","rawCompany":"astek","city":"Denver","state":"CO","isRemote":false,"isActive":false,"createdAt":"2026-09-06T08:22:37.012Z","occupations":[{"code":"15-2041.01","title":"Biostatisticians","slug":"biostatisticians"},{"code":"15-2041.00","title":"Statisticians","slug":"statisticians"},{"code":"15-2051.02","title":"Clinical Data Managers","slug":"clinical-data-managers"}],"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":"Lead Statistical Programmer","description":"ALSINOVA is actively hiring a Lead Statistical Programmer for a fully remote opportunity in US. You will work on programming activities across Phase I–III HIV & Immunology programs in a fast-paced environment, working closely with Biostatistics and Data Management teams.ResponsibilitiesLead end-to-end SDTM/ADaM dataset programming and validation across HIV study teamsServe as lead programmer, overseeing timelines, deliverables, and programming risk across multiple studiesDevelop and validate TLFs (tables, listings, figures) for CSRs, ISS/ISE, and interim analysesEnsure full CDISC compliance (SDTM, ADaM, Define.xml, ADRG/cSDRG) and Pinnacle 21 validationAuthor and review programming specifications, mock shells, and derivations aligned with the SAPSupport regulatory submissions (FDA/EMA), including IND/NDA/BLA deliverablesCollaborate cross-functionally with Biostatistics, Data Management, Clinical, and Regulatory teams to resolve submission-impacting issuesMentor and provide technical leadership to junior and mid-level programmersEstablish and maintain programming standards, SOPs, and QC processesRequirements8+ years SAS/R programming in clinical trials, including prior lead programmer experienceDemonstrated experience on HIV clinical trial programs preferredR proficiency mandatory (e.g., dplyr, tidyverse, ggplot2, R Shiny)Strong expertise in CDISC standards (SDTM, ADaM, Define.xml)Regulatory submission experience (FDA/EMA) requiredPhase I–III experience; infectious disease/virology background strongly preferredProven ability to lead and mentor programming teams","datePosted":"2026-09-06T08:22:37.012Z","dateModified":"2026-09-06T08:22:37.012Z","hiringOrganization":{"@type":"Organization","name":"Astek","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Denver","addressRegion":"CO","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ea273ba649d18316555596cb"},"url":"https://jobsearcher.com/jobs/ea273ba649d18316555596cb"}}