{"schemaVersion":"jobsearcher.job.v1","id":"9adf41e4e138c5726dcfa37f","url":"https://jobsearcher.com/jobs/9adf41e4e138c5726dcfa37f","canonicalUrl":"https://jobsearcher.com/jobs/9adf41e4e138c5726dcfa37f","title":"Principal Statistical Programmer","description":"Responsibilities:\nLead the development and validation of statistical programs to produce high-quality deliverables for in-house and outsourced projects, ensuring compliance with company and regulatory requirements.\nSupport ISS/ISE analyses for NDA submissions.\nAssist with project work to ensure timely, high-quality delivery across studies.\nCreate and review programming plans and specifications for datasets and TLFs. Requires advanced knowledge of CDISC standards, including SDTM and ADaM models, with experience in implementing these models.\nReview documents produced by biometric functions, such as SAP, CRFs, data review plans, and data transfer agreements.\nReview and validate deliverables produced by CROs, including SDTM, ADaM, and TLFs, and provide solutions to issues raised by CROs.\nReview e-submission datasets and data documentation, including aCRFs, reviewer guides, define.xml documents, and programs to ensure all files meet submission requirements.\nDevelop macros to support study and project activities, improving overall efficiency and capacity of the programming function.\nStay current with ICH guidelines and maintain advanced knowledge of submission requirements and standards.\nSupport the preparation of clinical study reports, regulatory submissions, annual DSURs, and safety reports for multiple studies.\nEffectively communicate within the project team environment, across departments, and with external collaborators.\nThe Ideal Candidate\nExpert-level SAS programmer with experience delivering complex programming assignments and analyses. Proficient in developing original code, including macros, as well as modifying existing code.\nAdvanced knowledge and extensive hands-on experience with CDISC standards, such as CDASH, SDTM, and ADaM.\nExperience in the drug development process and working with CROs.\nExperience with FDA/EMEA/CDE filings.\nStrong interpersonal and effective communication skills (oral and written).\nThorough attention to detail and consistency.\nEducation Requirement\nBachelor’s degree or equivalent education, preferably in a computational or biological science, with a minimum of 8 years of directly related experience in a drug development environment.\nOr a Master’s degree with a minimum of 6 years of related experience.","company":"Simulstat","rawCompany":"simulstat","city":"Remote","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-04-14T10:53:59.442Z","occupations":[{"code":"15-2041.01","title":"Biostatisticians","slug":"biostatisticians"},{"code":"15-2041.00","title":"Statisticians","slug":"statisticians"},{"code":"15-1251.00","title":"Computer Programmers","slug":"computer-programmers"}],"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":"Principal Statistical Programmer","description":"Responsibilities:\nLead the development and validation of statistical programs to produce high-quality deliverables for in-house and outsourced projects, ensuring compliance with company and regulatory requirements.\nSupport ISS/ISE analyses for NDA submissions.\nAssist with project work to ensure timely, high-quality delivery across studies.\nCreate and review programming plans and specifications for datasets and TLFs. Requires advanced knowledge of CDISC standards, including SDTM and ADaM models, with experience in implementing these models.\nReview documents produced by biometric functions, such as SAP, CRFs, data review plans, and data transfer agreements.\nReview and validate deliverables produced by CROs, including SDTM, ADaM, and TLFs, and provide solutions to issues raised by CROs.\nReview e-submission datasets and data documentation, including aCRFs, reviewer guides, define.xml documents, and programs to ensure all files meet submission requirements.\nDevelop macros to support study and project activities, improving overall efficiency and capacity of the programming function.\nStay current with ICH guidelines and maintain advanced knowledge of submission requirements and standards.\nSupport the preparation of clinical study reports, regulatory submissions, annual DSURs, and safety reports for multiple studies.\nEffectively communicate within the project team environment, across departments, and with external collaborators.\nThe Ideal Candidate\nExpert-level SAS programmer with experience delivering complex programming assignments and analyses. Proficient in developing original code, including macros, as well as modifying existing code.\nAdvanced knowledge and extensive hands-on experience with CDISC standards, such as CDASH, SDTM, and ADaM.\nExperience in the drug development process and working with CROs.\nExperience with FDA/EMEA/CDE filings.\nStrong interpersonal and effective communication skills (oral and written).\nThorough attention to detail and consistency.\nEducation Requirement\nBachelor’s degree or equivalent education, preferably in a computational or biological science, with a minimum of 8 years of directly related experience in a drug development environment.\nOr a Master’s degree with a minimum of 6 years of related experience.","datePosted":"2026-04-14T10:53:59.442Z","dateModified":"2026-04-14T10:53:59.442Z","hiringOrganization":{"@type":"Organization","name":"Simulstat","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"9adf41e4e138c5726dcfa37f"},"url":"https://jobsearcher.com/jobs/9adf41e4e138c5726dcfa37f"}}