{"schemaVersion":"jobsearcher.job.v1","id":"e4458afc4b2e90e8bf2c136a","url":"https://jobsearcher.com/jobs/e4458afc4b2e90e8bf2c136a","canonicalUrl":"https://jobsearcher.com/jobs/e4458afc4b2e90e8bf2c136a","title":"Senior Data Management and Data Quality Analyst","description":"Position Summary\nThe Senior Data Management and Data Quality Analyst leads study data acquisition, validation, loading, curation, and regulatory data quality activities supporting FDA OCS tools and enterprise platforms. The individual provides expertise in CDISC standards, FDA study data guidance, business rules, and data governance.\nPrimary Responsibilities\nPerform study data acquisition, validation, loading, and curation.\nValidate SDTM, ADaM, SEND, and ISS datasets.\nSupport DataFit validation and study data quality reviews.\nDevelop Data Quality Reports and dashboards.\nImplement FDA Business Rules and validation rules.\nSupport Data Governance activities.\nPerform root cause analysis of study data issues.\nCoordinate with OCS Clinical and Nonclinical Services.\nMaintain SOPs and operational documentation.\nSupport BIMO, Site Selection Tool, Data Central, SEND Explorer, and Study Data Platform.\nDesired Qualifications\nBachelor's or Master's degree in Computer Science, Life Sciences, Biostatistics, or related discipline.\n8+ years of FDA/CDISC data management experience.\nExpertise in SDTM, ADaM, SEND, ISS, Pinnacle 21, SAS, SQL.\nExperience supporting FDA regulatory review programs.\nPay: $145,000.00 - $150,000.00 per year\nWork Location: Remote","company":"Bits","rawCompany":"bits","city":"Remote","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-08-13T15:21:07.313Z","occupations":[{"code":"15-2051.02","title":"Clinical Data Managers","slug":"clinical-data-managers"},{"code":"15-1243.01","title":"Data Warehousing Specialists","slug":"data-warehousing-specialists"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-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":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Data Management and Data Quality Analyst","description":"Position Summary\nThe Senior Data Management and Data Quality Analyst leads study data acquisition, validation, loading, curation, and regulatory data quality activities supporting FDA OCS tools and enterprise platforms. The individual provides expertise in CDISC standards, FDA study data guidance, business rules, and data governance.\nPrimary Responsibilities\nPerform study data acquisition, validation, loading, and curation.\nValidate SDTM, ADaM, SEND, and ISS datasets.\nSupport DataFit validation and study data quality reviews.\nDevelop Data Quality Reports and dashboards.\nImplement FDA Business Rules and validation rules.\nSupport Data Governance activities.\nPerform root cause analysis of study data issues.\nCoordinate with OCS Clinical and Nonclinical Services.\nMaintain SOPs and operational documentation.\nSupport BIMO, Site Selection Tool, Data Central, SEND Explorer, and Study Data Platform.\nDesired Qualifications\nBachelor's or Master's degree in Computer Science, Life Sciences, Biostatistics, or related discipline.\n8+ years of FDA/CDISC data management experience.\nExpertise in SDTM, ADaM, SEND, ISS, Pinnacle 21, SAS, SQL.\nExperience supporting FDA regulatory review programs.\nPay: $145,000.00 - $150,000.00 per year\nWork Location: Remote","datePosted":"2026-08-13T15:21:07.313Z","dateModified":"2026-08-13T15:21:07.313Z","hiringOrganization":{"@type":"Organization","name":"Bits","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e4458afc4b2e90e8bf2c136a"},"url":"https://jobsearcher.com/jobs/e4458afc4b2e90e8bf2c136a"}}