{"schemaVersion":"jobsearcher.job.v1","id":"c7c8d0499ba992fcd2af0c1b","url":"https://jobsearcher.com/jobs/c7c8d0499ba992fcd2af0c1b","canonicalUrl":"https://jobsearcher.com/jobs/c7c8d0499ba992fcd2af0c1b","title":"Lead Statistical Programmer","description":"Responsibilities:\nConvert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs.\nBe responsible for overall project delivery, including clinical trial reports and other regulatory submission deliverables.\nCreate statistical analysis outputs to be used in support of final reports, abstracts, posters, Manu scripts, and other clinical publications; support systems to produce electronic regulatory submissions.\nAssist in establishing standardized programming procedures and work instructions.\nDevelop, enhance, evaluate, and validate standardized macros and utility programs to ensure that regulatory requirements are met through validation/compliance activities.\nDevelop and maintain clinical processing workflow systems.\nAssist in the development of client proposal documents.\nProvide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.\nProvide input into and negotiate statistical programming timelines. Ensure that timelines are adhered to and coordinate and lead a statistical programming team to successful completion of a study within given timelines and budgets.\nTrained in sponsor SOPs and disseminate knowledge to project team members as appropriate.\nProvide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) records handling (e.g., Chapter 21 of the US Code of Federal Regulation - Part and electronic submission of clinical data to agencies (e.g., e-CTD guidance and CDISC SDTM and ADaM standards).\nAssist in updating/writing PROMETRIKA standard operating procedures (SOPs).\nDevelop tools in SAS for data analysis and reporting that comply with regulatory requirements.\nDevelop specifications (e.g., metadata files), annotate CRFs and create SAS programs for the mapping of raw datasets to CDISC SDTM standards.\nCreate define.xml files from metadata files for SDTM and ADaM.\nConvert data received in other formats to SAS datasets.\nRequirements:\nMust have expertise in SAS/BASE, SAS/STAT, and knowledge of SAS/CONNECT, SAS/ACCESS, SAS/MACRO, SAS/GRAPH, SQL, and ODS.\nKnowledge of SDTM, ADaM, FDA and ICH guidance.\nUnderstanding of Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer systems.\nGood organizational skills across individual projects and managing own and teamwork loads. Ability to organize, manage and complete multiple assignments with challenging timelines independently and effectively.\nConsistent experience as a lead statistical programmer on several concurrent projects.\nStrong understanding of drug development, including knowledge of interfaces and interdependencies with other functions.\nStrong mentoring skills as shown by leadership of projects and if applicable, junior team members.\nExcellent analytical skills.\nProven ability to learn new systems and function in an evolving technical environment.\nAbility to negotiate and influence to achieve results.\nGood presentation skills.\nGood business awareness/business development skills (including financial awareness).\nAbility to create, maintain and define strategies to improve the efficiency of running a clinical trial.\nWork effectively in a quality-focused environment.\nKnowledge of other programming languages and database management software packages is a plus.","company":"Katalysthealthcares","rawCompany":"katalysthealthcares","city":"Millbrae","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-08-03T14:08:34.132Z","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":"Responsibilities:\nConvert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs.\nBe responsible for overall project delivery, including clinical trial reports and other regulatory submission deliverables.\nCreate statistical analysis outputs to be used in support of final reports, abstracts, posters, Manu scripts, and other clinical publications; support systems to produce electronic regulatory submissions.\nAssist in establishing standardized programming procedures and work instructions.\nDevelop, enhance, evaluate, and validate standardized macros and utility programs to ensure that regulatory requirements are met through validation/compliance activities.\nDevelop and maintain clinical processing workflow systems.\nAssist in the development of client proposal documents.\nProvide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.\nProvide input into and negotiate statistical programming timelines. Ensure that timelines are adhered to and coordinate and lead a statistical programming team to successful completion of a study within given timelines and budgets.\nTrained in sponsor SOPs and disseminate knowledge to project team members as appropriate.\nProvide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) records handling (e.g., Chapter 21 of the US Code of Federal Regulation - Part and electronic submission of clinical data to agencies (e.g., e-CTD guidance and CDISC SDTM and ADaM standards).\nAssist in updating/writing PROMETRIKA standard operating procedures (SOPs).\nDevelop tools in SAS for data analysis and reporting that comply with regulatory requirements.\nDevelop specifications (e.g., metadata files), annotate CRFs and create SAS programs for the mapping of raw datasets to CDISC SDTM standards.\nCreate define.xml files from metadata files for SDTM and ADaM.\nConvert data received in other formats to SAS datasets.\nRequirements:\nMust have expertise in SAS/BASE, SAS/STAT, and knowledge of SAS/CONNECT, SAS/ACCESS, SAS/MACRO, SAS/GRAPH, SQL, and ODS.\nKnowledge of SDTM, ADaM, FDA and ICH guidance.\nUnderstanding of Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer systems.\nGood organizational skills across individual projects and managing own and teamwork loads. Ability to organize, manage and complete multiple assignments with challenging timelines independently and effectively.\nConsistent experience as a lead statistical programmer on several concurrent projects.\nStrong understanding of drug development, including knowledge of interfaces and interdependencies with other functions.\nStrong mentoring skills as shown by leadership of projects and if applicable, junior team members.\nExcellent analytical skills.\nProven ability to learn new systems and function in an evolving technical environment.\nAbility to negotiate and influence to achieve results.\nGood presentation skills.\nGood business awareness/business development skills (including financial awareness).\nAbility to create, maintain and define strategies to improve the efficiency of running a clinical trial.\nWork effectively in a quality-focused environment.\nKnowledge of other programming languages and database management software packages is a plus.","datePosted":"2026-08-03T14:08:34.132Z","dateModified":"2026-08-03T14:08:34.132Z","hiringOrganization":{"@type":"Organization","name":"Katalysthealthcares","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Millbrae","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"c7c8d0499ba992fcd2af0c1b"},"url":"https://jobsearcher.com/jobs/c7c8d0499ba992fcd2af0c1b"}}