{"schemaVersion":"jobsearcher.job.v1","id":"195fb045ada6e17fe59d3b86","url":"https://jobsearcher.com/jobs/195fb045ada6e17fe59d3b86","canonicalUrl":"https://jobsearcher.com/jobs/195fb045ada6e17fe59d3b86","title":"Manager, Statistical Programming","description":"General Summary\nThe Manager of Statistical Programming will manage a team of statistical programmers engaged in medical device clinical research activities. The Manager of Statistical Programming provides statistical programming support for multiple projects through own efforts and those of staff for assigned projects. The manager builds relationships and promotes collaboration across functions with internal colleagues in Statistics, Data Management, Scientific Communications, Regulatory Medical Writing, and Clinical Study Management. This individual is responsible for ensuring the quality, integrity, and timely delivery of programming deliverables supporting clinical studies, publications, and regulatory submissions. The role drives programming standards, process improvements, innovations, and continuous improvement.\n\nSpecific Duties and Responsibilities\n\nSelect, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. *\nLead a team of statistical programmers. Attract, recruit, hire, and retain new staff.*\nLead resource planning for statistical programming team, including forecasting of employees and external resources (contractors, temps, CRO, consultants). *\nOversee team effort related to derive data sets and programs, and analysis data set specifications. *\nEnsure consistency analysis of data sets following appropriate standards for clinical studies. Ensure consistency within a therapeutic area.\nDevelop and oversee the development of statistical code for the creation of Tables, Listings and Figures for clinical studies. *\nEnsure that all quality processes are followed. Determine the scope of code verification and ensure completeness of verification for assigned projects. *\nProvide input into the development of CRFs and database designs, and definitions. Participate in the development of CRFs, edit check specifications, and data validation reports.\nParticipate in the review of SAP and Shells. Interpret the statistical analysis plans and develop analysis of dataset specifications. *\nCreation documentation for regulatory filings including reviewers, guides, and data definition documents. *\nMonitor and quantify efficiency, accuracy, and timeliness of the group.\nEnsure that appropriate concepts and techniques are implemented for clinical studies.\nResponsible for monitoring regulatory guidance and industry best practices related to output design and programming conventions.\n\nEnsure efficient programming techniques are utilized by programmers.\nWork collaboratively with multiple stakeholders, propose solutions for potential problems within and across projects, and develop appropriate contingency plans.\nLead the development of standard code (e.g., SAS, R, Python, Git) and the development of standard operating procedures. Maintain expertise in SAS macros and propose new macros. Mentor others on existing Macros. Oversee the development of new SAS Macros. *\nManage CROs and other outside vendors for statistical programming activities for clinical studies when appropriate for clinical study data analysis needs. Oversees outsourced programming by providing ongoing reviews of activities and progress to ensure projects are delivered on time with suitable quality.\nAdhere to the Company’s Quality Management System (QMS) as well as domestic and\nglobal quality system regulations, standards, and procedures. *\n\nUnderstand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *\nEnsure other members of the department to follow the QMS, regulations, standards, and procedures. *\nPerform other work-related duties as assigned.\nIndicates an essential function of the role\n\nRequired Qualifications\nMinimum education and experience:\n\nBachelor’s degree in Statistics, Data Science, Computer Science, Mathematics, or related field with 8+ years of experience or equivalent combination of education and experience.\nIn-depth knowledge of statistical programming concepts and techniques related to medical devices or drug development is required.\nPreferred Qualifications:\n\nMaster’s or higher degree preferred in Statistics, Data Science, Computer Science, Mathematics, or related field with 6+ years of relevant experience.\n1+ years of experience in a supervisory role desired.\nStrong leadership and interpersonal skills are highly desired.\nMedical device, pharmaceutical, biotech, or other regulated industry experience desired.\nRegulatory filing experience preferred.\nExperience with clinical trials, including familiarity with expectations of regulatory agencies (e.g., FDA, PDMA) preferred.\nAble to effectively represent the clinical statistical programming function in cross functional teams.\nAble to accurately estimate the effort required for project related programming activities.\nHigh degree of technical competence and communication ability, both oral and written.\nUnderstanding of ICH guidelines and relevant regulatory requirements.\nExcellent problem-solving skills, with a demonstrated ability to guide programmers.\nExcellent organizational skills with ability to prioritize assignments while handling various projects simultaneously.\nHigh degree of accuracy and attention to detail.\nCompetent in statistical programming and Macro development.\n\nWorking Conditions\n\nGeneral office environment.\nWillingness and ability to work on site. May have business travel from 5% - 10%.\nRequires some lifting and moving of up to 10 pounds.\nMust be able to move between buildings and floors.\nMust be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.\nMust be able to read, prepare emails, and produce documents and spreadsheets.\nMust be able to move within the office and access file cabinets or supplies, as needed.\nMust be able to communicate and exchange accurate information with employees at all levels on a daily basis.\n\nAnnual Base Salary Range: $158,000 - $227,000\nThis is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.\nWhat We Offer\nA collaborative teamwork environment where learning is constant, and performance is rewarded.\nThe opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.\nA generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).\nPenumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.\nQualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.\nIf you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.\nFor additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.","company":"Penumbra","rawCompany":"penumbra","city":"Remote","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-08-04T19:26:54.745Z","occupations":[{"code":"11-9121.00","title":"Natural Sciences Managers","slug":"natural-sciences-managers"},{"code":"15-2041.00","title":"Statisticians","slug":"statisticians"},{"code":"15-2041.01","title":"Biostatisticians","slug":"biostatisticians"}],"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":"Manager, Statistical Programming","description":"General Summary\nThe Manager of Statistical Programming will manage a team of statistical programmers engaged in medical device clinical research activities. The Manager of Statistical Programming provides statistical programming support for multiple projects through own efforts and those of staff for assigned projects. The manager builds relationships and promotes collaboration across functions with internal colleagues in Statistics, Data Management, Scientific Communications, Regulatory Medical Writing, and Clinical Study Management. This individual is responsible for ensuring the quality, integrity, and timely delivery of programming deliverables supporting clinical studies, publications, and regulatory submissions. The role drives programming standards, process improvements, innovations, and continuous improvement.\n\nSpecific Duties and Responsibilities\n\nSelect, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. *\nLead a team of statistical programmers. Attract, recruit, hire, and retain new staff.*\nLead resource planning for statistical programming team, including forecasting of employees and external resources (contractors, temps, CRO, consultants). *\nOversee team effort related to derive data sets and programs, and analysis data set specifications. *\nEnsure consistency analysis of data sets following appropriate standards for clinical studies. Ensure consistency within a therapeutic area.\nDevelop and oversee the development of statistical code for the creation of Tables, Listings and Figures for clinical studies. *\nEnsure that all quality processes are followed. Determine the scope of code verification and ensure completeness of verification for assigned projects. *\nProvide input into the development of CRFs and database designs, and definitions. Participate in the development of CRFs, edit check specifications, and data validation reports.\nParticipate in the review of SAP and Shells. Interpret the statistical analysis plans and develop analysis of dataset specifications. *\nCreation documentation for regulatory filings including reviewers, guides, and data definition documents. *\nMonitor and quantify efficiency, accuracy, and timeliness of the group.\nEnsure that appropriate concepts and techniques are implemented for clinical studies.\nResponsible for monitoring regulatory guidance and industry best practices related to output design and programming conventions.\n\nEnsure efficient programming techniques are utilized by programmers.\nWork collaboratively with multiple stakeholders, propose solutions for potential problems within and across projects, and develop appropriate contingency plans.\nLead the development of standard code (e.g., SAS, R, Python, Git) and the development of standard operating procedures. Maintain expertise in SAS macros and propose new macros. Mentor others on existing Macros. Oversee the development of new SAS Macros. *\nManage CROs and other outside vendors for statistical programming activities for clinical studies when appropriate for clinical study data analysis needs. Oversees outsourced programming by providing ongoing reviews of activities and progress to ensure projects are delivered on time with suitable quality.\nAdhere to the Company’s Quality Management System (QMS) as well as domestic and\nglobal quality system regulations, standards, and procedures. *\n\nUnderstand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *\nEnsure other members of the department to follow the QMS, regulations, standards, and procedures. *\nPerform other work-related duties as assigned.\nIndicates an essential function of the role\n\nRequired Qualifications\nMinimum education and experience:\n\nBachelor’s degree in Statistics, Data Science, Computer Science, Mathematics, or related field with 8+ years of experience or equivalent combination of education and experience.\nIn-depth knowledge of statistical programming concepts and techniques related to medical devices or drug development is required.\nPreferred Qualifications:\n\nMaster’s or higher degree preferred in Statistics, Data Science, Computer Science, Mathematics, or related field with 6+ years of relevant experience.\n1+ years of experience in a supervisory role desired.\nStrong leadership and interpersonal skills are highly desired.\nMedical device, pharmaceutical, biotech, or other regulated industry experience desired.\nRegulatory filing experience preferred.\nExperience with clinical trials, including familiarity with expectations of regulatory agencies (e.g., FDA, PDMA) preferred.\nAble to effectively represent the clinical statistical programming function in cross functional teams.\nAble to accurately estimate the effort required for project related programming activities.\nHigh degree of technical competence and communication ability, both oral and written.\nUnderstanding of ICH guidelines and relevant regulatory requirements.\nExcellent problem-solving skills, with a demonstrated ability to guide programmers.\nExcellent organizational skills with ability to prioritize assignments while handling various projects simultaneously.\nHigh degree of accuracy and attention to detail.\nCompetent in statistical programming and Macro development.\n\nWorking Conditions\n\nGeneral office environment.\nWillingness and ability to work on site. May have business travel from 5% - 10%.\nRequires some lifting and moving of up to 10 pounds.\nMust be able to move between buildings and floors.\nMust be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.\nMust be able to read, prepare emails, and produce documents and spreadsheets.\nMust be able to move within the office and access file cabinets or supplies, as needed.\nMust be able to communicate and exchange accurate information with employees at all levels on a daily basis.\n\nAnnual Base Salary Range: $158,000 - $227,000\nThis is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.\nWhat We Offer\nA collaborative teamwork environment where learning is constant, and performance is rewarded.\nThe opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.\nA generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).\nPenumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.\nQualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.\nIf you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.\nFor additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.","datePosted":"2026-08-04T19:26:54.745Z","dateModified":"2026-08-04T19:26:54.745Z","hiringOrganization":{"@type":"Organization","name":"Penumbra","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"195fb045ada6e17fe59d3b86"},"url":"https://jobsearcher.com/jobs/195fb045ada6e17fe59d3b86"}}