{"schemaVersion":"jobsearcher.job.v1","id":"46ca62a1a4a5fe6cc8f949ab","url":"https://jobsearcher.com/jobs/46ca62a1a4a5fe6cc8f949ab","canonicalUrl":"https://jobsearcher.com/jobs/46ca62a1a4a5fe6cc8f949ab","title":"Senior Principal Statistical Programmer","description":"Summary of Position\r\nThe Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing.\r\nDuties and Responsibilities\r\nReview protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.\r\nReview CRF, database design, and edit check specs\r\nReview study quality surveillance plan and monitor study conduct\r\nPrepare and/or review SAP, TFL shells and specifications for variable derivation\r\nWork closely with Statistical Programmers and Clinical Data Manager to identify data quality issues for key efficacy and safety variables\r\nProvide statistical and validation support for statistical analysis, analysis datasets and TFL\r\nReview study report, manuscripts and other documents related to statistics\r\nWork on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents\r\nPerform other ad-hoc statistical activities as needed\r\nWorks effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming\r\nParticipates in monitoring CRO activities and reviewing CRO deliverables\r\nOther duties as assigned\r\nMust have\r\nPh.D or MS in Statistics or Biostatistics\r\nMinimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience\r\nExcellent knowledge of SAS computer package\r\nExcellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines\r\nExcellent organizational skills, time management, and ability to meet established deadlines\r\nExcellent communication and interpersonal skills to effectively interface with others\r\nAbility to work independently and problem-solve\r\nAbility to provide leadership for the CRO statisticians and statistical programmers\r\nJ-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Paramus","state":"NJ","isRemote":false,"isActive":false,"createdAt":"2026-07-16T01:29:39.543Z","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":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"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":"Senior Principal Statistical Programmer","description":"Summary of Position\r\nThe Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing.\r\nDuties and Responsibilities\r\nReview protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.\r\nReview CRF, database design, and edit check specs\r\nReview study quality surveillance plan and monitor study conduct\r\nPrepare and/or review SAP, TFL shells and specifications for variable derivation\r\nWork closely with Statistical Programmers and Clinical Data Manager to identify data quality issues for key efficacy and safety variables\r\nProvide statistical and validation support for statistical analysis, analysis datasets and TFL\r\nReview study report, manuscripts and other documents related to statistics\r\nWork on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents\r\nPerform other ad-hoc statistical activities as needed\r\nWorks effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming\r\nParticipates in monitoring CRO activities and reviewing CRO deliverables\r\nOther duties as assigned\r\nMust have\r\nPh.D or MS in Statistics or Biostatistics\r\nMinimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience\r\nExcellent knowledge of SAS computer package\r\nExcellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines\r\nExcellent organizational skills, time management, and ability to meet established deadlines\r\nExcellent communication and interpersonal skills to effectively interface with others\r\nAbility to work independently and problem-solve\r\nAbility to provide leadership for the CRO statisticians and statistical programmers\r\nJ-18808-Ljbffr","datePosted":"2026-07-16T01:29:39.543Z","dateModified":"2026-07-16T01:29:39.543Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Paramus","addressRegion":"NJ","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"46ca62a1a4a5fe6cc8f949ab"},"url":"https://jobsearcher.com/jobs/46ca62a1a4a5fe6cc8f949ab"}}