{"schemaVersion":"jobsearcher.job.v1","id":"a3d6202bbe2b38e375aa63e7","url":"https://jobsearcher.com/jobs/a3d6202bbe2b38e375aa63e7","canonicalUrl":"https://jobsearcher.com/jobs/a3d6202bbe2b38e375aa63e7","title":"Clinical Programmer","description":"Summary\nThis position is responsible for leading statistical programming activities to support clinical development projects, regulatory submissions, and lifecycle management of biopharmaceutical products. This role ensures the accuracy, integrity, and compliance of clinical data analysis through advanced programming expertise and cross-functional collaboration. This position reports directly to the ‌Senior Director and Head of Biometrics‌.\n\nEducation and Experience\nMS in Computer Science/Biostatistics/Statistics or related field\n5+ years of experience in statistical programming within the biotechnology, pharmaceutical, or clinical research industry.\nProven experience managing multiple projects simultaneously.\nExperience in therapeutic areas such as diabetes, obesity or metabolic disease is highly desirable.\nPrior experience in regulatory interactions (e.g., FDA, EMA) and submissions is required\n\nSkills and Qualifications\nAdvanced proficiency in SAS. Other statistical programming languages such as R and Python are desirable.\nIn-depth knowledge of CDISC standards (SDTM, ADaM) and clinical data structures.\nFamiliarity with clinical trial design, data integration, and electronic submission requirements (e.g., eCTD).\nThorough understanding of global regulatory guidelines (e.g., ICH-GCP, FDA/EMA regulations) and industry best practices.\nCapable of developing innovative programming solutions to address complex data challenges.\nHighly effective written, oral, and interpersonal communication skills as well as ability to work in interdisciplinary contexts outside statistics.\nResponsibilities\nLead the development and validation of datasets, tables, listings, and figures (TLFs) for clinical study reports and regulatory submissions.\nOversee the implementation of CDISC standards and ensure programming alignment with statistical analysis plans (SAPs).\nContribute to the preparation of integrated summaries of efficacy/safety (ISE/ISS) and other submission documents.\nAddress statistical programming inquiries from health authorities and external partners.\nWork closely with biostatisticians to optimize data analysis strategies and ensure accurate interpretation of results.\nCoordinate with data management function to validate data quality and resolve discrepancies.\nDevelop and implement programming standards, tools, and SOPs to enhance efficiency and compliance.\nEnsure all programming activities adhere to regulatory requirements and company quality standards.\n\nt3IoqRJaa0","company":"Gan","rawCompany":"gan","city":"Remote","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-04-14T10:26:20.102Z","occupations":[{"code":"15-2041.01","title":"Biostatisticians","slug":"biostatisticians"},{"code":"15-2051.02","title":"Clinical Data Managers","slug":"clinical-data-managers"},{"code":"15-2041.00","title":"Statisticians","slug":"statisticians"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"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"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Clinical Programmer","description":"Summary\nThis position is responsible for leading statistical programming activities to support clinical development projects, regulatory submissions, and lifecycle management of biopharmaceutical products. This role ensures the accuracy, integrity, and compliance of clinical data analysis through advanced programming expertise and cross-functional collaboration. This position reports directly to the ‌Senior Director and Head of Biometrics‌.\n\nEducation and Experience\nMS in Computer Science/Biostatistics/Statistics or related field\n5+ years of experience in statistical programming within the biotechnology, pharmaceutical, or clinical research industry.\nProven experience managing multiple projects simultaneously.\nExperience in therapeutic areas such as diabetes, obesity or metabolic disease is highly desirable.\nPrior experience in regulatory interactions (e.g., FDA, EMA) and submissions is required\n\nSkills and Qualifications\nAdvanced proficiency in SAS. Other statistical programming languages such as R and Python are desirable.\nIn-depth knowledge of CDISC standards (SDTM, ADaM) and clinical data structures.\nFamiliarity with clinical trial design, data integration, and electronic submission requirements (e.g., eCTD).\nThorough understanding of global regulatory guidelines (e.g., ICH-GCP, FDA/EMA regulations) and industry best practices.\nCapable of developing innovative programming solutions to address complex data challenges.\nHighly effective written, oral, and interpersonal communication skills as well as ability to work in interdisciplinary contexts outside statistics.\nResponsibilities\nLead the development and validation of datasets, tables, listings, and figures (TLFs) for clinical study reports and regulatory submissions.\nOversee the implementation of CDISC standards and ensure programming alignment with statistical analysis plans (SAPs).\nContribute to the preparation of integrated summaries of efficacy/safety (ISE/ISS) and other submission documents.\nAddress statistical programming inquiries from health authorities and external partners.\nWork closely with biostatisticians to optimize data analysis strategies and ensure accurate interpretation of results.\nCoordinate with data management function to validate data quality and resolve discrepancies.\nDevelop and implement programming standards, tools, and SOPs to enhance efficiency and compliance.\nEnsure all programming activities adhere to regulatory requirements and company quality standards.\n\nt3IoqRJaa0","datePosted":"2026-04-14T10:26:20.102Z","dateModified":"2026-04-14T10:26:20.102Z","hiringOrganization":{"@type":"Organization","name":"Gan","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"a3d6202bbe2b38e375aa63e7"},"url":"https://jobsearcher.com/jobs/a3d6202bbe2b38e375aa63e7"}}