{"schemaVersion":"jobsearcher.job.v1","id":"b8194a9d9d10cf92e3d9909f","url":"https://jobsearcher.com/jobs/b8194a9d9d10cf92e3d9909f","canonicalUrl":"https://jobsearcher.com/jobs/b8194a9d9d10cf92e3d9909f","title":"Manager, Statistical Programming","description":"Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.\r\nRezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders\r\nMore information can be found at rezolutebio.com\r\nPosition SummaryThe Manager of Statistical Programming is responsible for delivering study-level programming deliverables and milestones. The role combines hands-on programming in SAS and R with oversight of a small team or of CRO programmers assigned to a study.\r\nThe position requires working knowledge of statistical programming languages and software, clinical trial data, and the drug development process. The incumbent develops and oversees programs that generate CDISC-compliant SDTM and ADaM datasets, TLFs, and reports supporting the review of clinical data. The incumbent also writes validation programs and general-purpose code, prepares documentation to support electronic submissions, and contributes to programming standards and templates.\r\nResponsibilitiesPlans and delivers statistical programming for assigned studies in support of clinical trials, regulatory submissions, publications, and ad hoc analysis requests, following applicable regulatory guidelines and standards.\r\nTracks programming timelines for assigned studies and flags risks to the Director so deliverables stay aligned with the study schedule.\r\nCreates or oversees the creation of CDISC-compliant SDTM and ADaM datasets, and performs conformance checks (e.g., Pinnacle 21) before delivery.\r\nDevelops and validates TLFs and analysis datasets using SAS and R; performs independent QC of programming produced by others, including cross-language validation where appropriate.\r\nAssigns and reviews the work of a small team of internal programmers and/or CRO programmers; provides day-to-day direction, feedback, and mentoring.\r\nReviews CRO deliverables, specifications, and documentation for quality and standards compliance, and escalates issues as needed.\r\nParticipates in study meetings with Clinical Operations, Data Management, Safety, and Biostatistics to develop specifications and reports.\r\nWrites and maintains batch scripts to schedule SAS and R jobs and distribute reports to the clinical team.\r\nPrepares programming documentation supporting electronic submissions, including define.xml inputs and reviewer guide content.\r\nContributes to the development of SAS macros, R functions, standards, templates, and SOPs, and to cross-functional initiatives.\r\nProvides input on programming tools and infrastructure needs, including SAS and R environments, and works with IT as needed.\r\nQualificationsBS/BA in Statistics, Computer Science, Mathematics, Life Sciences, or a related field; MS preferred.\r\n8+ years of statistical programming experience in pharma, biotech, or CRO with a BS, or 6+ years with an MS.\r\n1–2 years of experience supervising programmers or serving as lead programmer on a study.\r\nStrong SAS skills (Base, Macro, SQL, STAT, ODS/Graph).\r\nWorking proficiency in R for clinical data manipulation, analysis, and reporting (e.g., tidyverse, admiral, gt, rtables, or similar).\r\nExperience developing R Shiny applications for interactive data review, safety monitoring, or visualization of clinical trial data is a plus.\r\nWorking knowledge of CDISC SDTM and ADaM, controlled terminology, and Define‑XML.\r\nFamiliarity with ICH guidelines and GCP; exposure to a regulatory submission is a plus.\r\nExperience with Python for automation, data processing, or tooling is a plus.\r\nClear written and verbal communication; comfortable working directly with statisticians and clinical teams.\r\nRezolute (RZLT) currently anticipates the base salary for the Manager of Statistical programming role could range from$160,000 to $195,000and will depend in part on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience, and geographical location of the selected candidate.\r\nQualifying employees are eligible to participate in benefit programs such as:\r\nHealth Insurance (Medical / Dental / Vision)\r\nDisability, Life & Long-Term Care Insurance\r\nHoliday Pay\r\nTracking Free Vacation Program\r\n401(k) Plan Match\r\nEducational Assistance Benefit\r\nFitness Center Reimbursement\r\nWe are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.#J-18808-Ljbffr","company":"Rezolute","rawCompany":"rezolute","city":"Brooklyn","state":"NY","isRemote":false,"isActive":false,"createdAt":"2026-10-14T02:53:16.542Z","occupations":[{"code":"15-2041.01","title":"Biostatisticians","slug":"biostatisticians"},{"code":"15-2041.00","title":"Statisticians","slug":"statisticians"},{"code":"11-9121.00","title":"Natural Sciences Managers","slug":"natural-sciences-managers"}],"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":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Manager, Statistical Programming","description":"Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.\r\nRezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders\r\nMore information can be found at rezolutebio.com\r\nPosition SummaryThe Manager of Statistical Programming is responsible for delivering study-level programming deliverables and milestones. The role combines hands-on programming in SAS and R with oversight of a small team or of CRO programmers assigned to a study.\r\nThe position requires working knowledge of statistical programming languages and software, clinical trial data, and the drug development process. The incumbent develops and oversees programs that generate CDISC-compliant SDTM and ADaM datasets, TLFs, and reports supporting the review of clinical data. The incumbent also writes validation programs and general-purpose code, prepares documentation to support electronic submissions, and contributes to programming standards and templates.\r\nResponsibilitiesPlans and delivers statistical programming for assigned studies in support of clinical trials, regulatory submissions, publications, and ad hoc analysis requests, following applicable regulatory guidelines and standards.\r\nTracks programming timelines for assigned studies and flags risks to the Director so deliverables stay aligned with the study schedule.\r\nCreates or oversees the creation of CDISC-compliant SDTM and ADaM datasets, and performs conformance checks (e.g., Pinnacle 21) before delivery.\r\nDevelops and validates TLFs and analysis datasets using SAS and R; performs independent QC of programming produced by others, including cross-language validation where appropriate.\r\nAssigns and reviews the work of a small team of internal programmers and/or CRO programmers; provides day-to-day direction, feedback, and mentoring.\r\nReviews CRO deliverables, specifications, and documentation for quality and standards compliance, and escalates issues as needed.\r\nParticipates in study meetings with Clinical Operations, Data Management, Safety, and Biostatistics to develop specifications and reports.\r\nWrites and maintains batch scripts to schedule SAS and R jobs and distribute reports to the clinical team.\r\nPrepares programming documentation supporting electronic submissions, including define.xml inputs and reviewer guide content.\r\nContributes to the development of SAS macros, R functions, standards, templates, and SOPs, and to cross-functional initiatives.\r\nProvides input on programming tools and infrastructure needs, including SAS and R environments, and works with IT as needed.\r\nQualificationsBS/BA in Statistics, Computer Science, Mathematics, Life Sciences, or a related field; MS preferred.\r\n8+ years of statistical programming experience in pharma, biotech, or CRO with a BS, or 6+ years with an MS.\r\n1–2 years of experience supervising programmers or serving as lead programmer on a study.\r\nStrong SAS skills (Base, Macro, SQL, STAT, ODS/Graph).\r\nWorking proficiency in R for clinical data manipulation, analysis, and reporting (e.g., tidyverse, admiral, gt, rtables, or similar).\r\nExperience developing R Shiny applications for interactive data review, safety monitoring, or visualization of clinical trial data is a plus.\r\nWorking knowledge of CDISC SDTM and ADaM, controlled terminology, and Define‑XML.\r\nFamiliarity with ICH guidelines and GCP; exposure to a regulatory submission is a plus.\r\nExperience with Python for automation, data processing, or tooling is a plus.\r\nClear written and verbal communication; comfortable working directly with statisticians and clinical teams.\r\nRezolute (RZLT) currently anticipates the base salary for the Manager of Statistical programming role could range from$160,000 to $195,000and will depend in part on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience, and geographical location of the selected candidate.\r\nQualifying employees are eligible to participate in benefit programs such as:\r\nHealth Insurance (Medical / Dental / Vision)\r\nDisability, Life & Long-Term Care Insurance\r\nHoliday Pay\r\nTracking Free Vacation Program\r\n401(k) Plan Match\r\nEducational Assistance Benefit\r\nFitness Center Reimbursement\r\nWe are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.#J-18808-Ljbffr","datePosted":"2026-10-14T02:53:16.542Z","dateModified":"2026-10-14T02:53:16.542Z","hiringOrganization":{"@type":"Organization","name":"Rezolute","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Brooklyn","addressRegion":"NY","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"b8194a9d9d10cf92e3d9909f"},"url":"https://jobsearcher.com/jobs/b8194a9d9d10cf92e3d9909f"}}