{"schemaVersion":"jobsearcher.job.v1","id":"7e2fb74d0edf98013ef111af","url":"https://jobsearcher.com/jobs/7e2fb74d0edf98013ef111af","canonicalUrl":"https://jobsearcher.com/jobs/7e2fb74d0edf98013ef111af","title":"Sr Statistical Programmer","description":"Full Time\nREMOTE, MA 1 Year Ago\nJob Description\nResponsibilities:\nConduct a comprehensive review of study documents, including Protocol, CRF, and SAP.\nCreate and assess statistical programs in SAS and/or R to produce CDISC-compliant SDTM and ADaM datasets.\nExecution of validation and quality control procedures for programs, datasets, and statistical reports, ensuring alignment with study requirements.\nDevelopment and review CDISC SDTM and ADaM mapping specifications.\nProduce and review Tables, Figures, and Listings (TFLs) in accordance with the SAP.\nReview datasets for any pending compliance issues and meticulously document identified issues.\nGeneration and review of submission documents like define.xml, SDTM annotated CRF, and reviewers guide.\nGeneration of utility macros and efficient code writing to streamline programming processes.\nCommunicate effectively within project teams to ensure the timely and budget-compliant completion of assigned tasks.\nAdherence to Clymb and/or client’s Policies and Procedures.\nRequirements:\nMaster’s degree or equivalent, along with relevant formal academic/vocational qualifications and a minimum of 5 years of SAS programming experience. Alternatively, a Bachelor’s degree with 7+ years of SAS programming experience.\nA minimum of 3 years of hands-on CDISC implementation experience. Any experience with R programming will be considered a significant plus.\nSignificant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.\nPrevious involvement as a production or QC programmer at both product and study levels.\nStrong organizational, interpersonal, leadership, and communication skills.\nAbility to autonomously manage multiple tasks and projects.\nIn-depth understanding of FDA regulatory guidance around Study Data and Submission, including familiarity with the Study Data Technical Conformance Guide, FDA Data Submission Standards Catalog, and associated requirements.\nA minimum requirement of a strong understanding of CDISC Metadata Submission Guidelines (MSG), Define standards, CDASH, SDTM, ADaM, and controlled terminology standards.\nSkills:\nStatistical Programming","company":"Clinical Data Solution","rawCompany":"clinical data solution","city":"Washington","state":"DC","isRemote":false,"isActive":false,"createdAt":"2026-08-07T10:02:31.205Z","occupations":[{"code":"15-2041.00","title":"Statisticians","slug":"statisticians"},{"code":"15-2041.01","title":"Biostatisticians","slug":"biostatisticians"},{"code":"15-2051.02","title":"Clinical Data Managers","slug":"clinical-data-managers"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr Statistical Programmer","description":"Full Time\nREMOTE, MA 1 Year Ago\nJob Description\nResponsibilities:\nConduct a comprehensive review of study documents, including Protocol, CRF, and SAP.\nCreate and assess statistical programs in SAS and/or R to produce CDISC-compliant SDTM and ADaM datasets.\nExecution of validation and quality control procedures for programs, datasets, and statistical reports, ensuring alignment with study requirements.\nDevelopment and review CDISC SDTM and ADaM mapping specifications.\nProduce and review Tables, Figures, and Listings (TFLs) in accordance with the SAP.\nReview datasets for any pending compliance issues and meticulously document identified issues.\nGeneration and review of submission documents like define.xml, SDTM annotated CRF, and reviewers guide.\nGeneration of utility macros and efficient code writing to streamline programming processes.\nCommunicate effectively within project teams to ensure the timely and budget-compliant completion of assigned tasks.\nAdherence to Clymb and/or client’s Policies and Procedures.\nRequirements:\nMaster’s degree or equivalent, along with relevant formal academic/vocational qualifications and a minimum of 5 years of SAS programming experience. Alternatively, a Bachelor’s degree with 7+ years of SAS programming experience.\nA minimum of 3 years of hands-on CDISC implementation experience. Any experience with R programming will be considered a significant plus.\nSignificant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.\nPrevious involvement as a production or QC programmer at both product and study levels.\nStrong organizational, interpersonal, leadership, and communication skills.\nAbility to autonomously manage multiple tasks and projects.\nIn-depth understanding of FDA regulatory guidance around Study Data and Submission, including familiarity with the Study Data Technical Conformance Guide, FDA Data Submission Standards Catalog, and associated requirements.\nA minimum requirement of a strong understanding of CDISC Metadata Submission Guidelines (MSG), Define standards, CDASH, SDTM, ADaM, and controlled terminology standards.\nSkills:\nStatistical Programming","datePosted":"2026-08-07T10:02:31.205Z","dateModified":"2026-08-07T10:02:31.205Z","hiringOrganization":{"@type":"Organization","name":"Clinical Data Solution","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Washington","addressRegion":"DC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"7e2fb74d0edf98013ef111af"},"url":"https://jobsearcher.com/jobs/7e2fb74d0edf98013ef111af"}}