{"schemaVersion":"jobsearcher.job.v1","id":"8253fa202c32baca420797db","url":"https://jobsearcher.com/jobs/8253fa202c32baca420797db","canonicalUrl":"https://jobsearcher.com/jobs/8253fa202c32baca420797db","title":"Manager, Statistical Programming","description":"Manager, Statistical ProgrammingAt Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to \"be an innovative global healthcare company contributing to the sustainable development of society\", we are shaping a healthier, more hopeful future for patients, their families, and society.Job SummaryThe purpose of this role is to lead and contribute to statistical programming activities across SDTM, ADaM, and Tables, Listings, and Figures (TLFs), providing both technical oversight and hands-on support for the development, validation, and programmatic review of datasets and outputs. This role ensures the quality, consistency, and timeliness of deliverables supporting oncology regulatory submissions by guiding programming strategies, reviewing key outputs, and driving issue resolution. In addition, the position fosters and maintains institutional knowledge across oncology compounds, while supporting the development, standardization, and continuous improvement of programming processes and best practices for datasets and TLFs to enhance efficiency, quality, and compliance.ResponsibilitiesLead and execute statistical programming activities by developing and validating datasets and Tables, Listings, and Figures (TLFs) to ensure high-quality deliverables for pivotal studies, as well as Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS) for oncology regulatory submissions.Drive end-to-end programming from SDTM through ADaM to TLF generation in compliance with CDISC standards and regulatory requirements.Develop SDTM CRF annotations and SDTM specifications, and analysis dataset specifications to ensure accurate implementation of SAPs and TLF shells; perform hands-on programming to create and validate SDTM and ADaM datasets and TLFs, ensuring quality, integrity, and submission readiness; conduct comprehensive reviews of submission data packages to ensure quality, completeness, and alignment with regulatory expectations.Manage and coordinate statistical programming activities for project planning and delivery to ensure high-quality outputs and adherence to timelines.Develop and manage programming timelines and resource plans; collaborate closely with Biostatistics, Data Management, and cross-functional teams to ensure efficient and accurate execution; manage the generation and tracking of datasets and TLFs for ongoing and completed studies; ensure appropriate data usage and high-quality outputs; proactively identify and resolve programming-related issues prior to database lock and analysis; maintain all required documentation in compliance with Trial Master File (TMF) requirements.For outsourced studies, oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met.Review and agree on vendor project timelines and resource planning; work in tandem with Biostatistics and Data Management members to ensure best vendor performance; monitor analysis dataset and TLF transfers for ongoing and complete trials; confirm data use and output quality; proactively ensure the resolution of programming-related issues prior to database lock and analysis; be accountable and verify completeness of study programming deliverables; maintain all required documentation for TMF.Maintain institutional knowledge across oncology compounds and support the development of standardized programming practices for datasets and TLFs to improve efficiency and quality.Contribute to CRF and SDTM standard development; support the development, implementation, and maintenance of Analysis Data Model (ADaM) datasets and TLF standards; support training initiatives to ensure consistent implementation of ADaM and TLF standards in clinical trial analyses.Provide programming support to prepare regulatory-requested analyses and help the submission team achieve quick turnaround in response to regulatory agencies.Develop TLFs to support submission-related QAs with quick turnaround timelines; support ad-hoc and exploratory analyses requested by clinical teams; provide programming support for regulatory responses and potential Advisory Committee meetings.Develop and maintain programming macros to effectively support internal data review and monitoring.Collaborate with Biostatistics team members to define requirements for efficacy data review; develop and enhance macros; support the internal data review and monitoring activities.QualificationsEducation QualificationsMaster's Degree in Biostatistics or a similar degree required.PhD in Biostatistics or a similar degree preferred.Experience Qualifications6+ years of proven experience within the pharmaceutical industry or CROs supporting statistical analysis of clinical trial programming, with a master's degree required.Oncology experience required.Advanced working knowledge of all aspects of the SAS programming language used in clinical trial programming.Advanced working knowledge of CDISC SDTM and ADaM, and extensive experience with their implementation in clinical trial analysis.Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials.Knowledge of all phases of drug development, including early and late phase clinical development and global submission.Experience with R and Python programming languages.Familiarity with AI/ML and their applications in clinical data analysis.Experience supporting and maintaining a statistical computing environment and clinical data repository system.Travel RequirementsAbility to travel up to 10% of the time.Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.Salary Range: USD$140,400.00 - USD$210,600.00J-18808-Ljbffr","company":"Initial Therapeutics","rawCompany":"initial therapeutics","city":"Basking Ridge","state":"NJ","isRemote":false,"isActive":false,"createdAt":"2026-05-28T02:56:52.968Z","occupations":[{"code":"15-2041.00","title":"Statisticians","slug":"statisticians"},{"code":"15-2041.01","title":"Biostatisticians","slug":"biostatisticians"},{"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":"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":"Manager, Statistical Programming","description":"Manager, Statistical ProgrammingAt Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to \"be an innovative global healthcare company contributing to the sustainable development of society\", we are shaping a healthier, more hopeful future for patients, their families, and society.Job SummaryThe purpose of this role is to lead and contribute to statistical programming activities across SDTM, ADaM, and Tables, Listings, and Figures (TLFs), providing both technical oversight and hands-on support for the development, validation, and programmatic review of datasets and outputs. This role ensures the quality, consistency, and timeliness of deliverables supporting oncology regulatory submissions by guiding programming strategies, reviewing key outputs, and driving issue resolution. In addition, the position fosters and maintains institutional knowledge across oncology compounds, while supporting the development, standardization, and continuous improvement of programming processes and best practices for datasets and TLFs to enhance efficiency, quality, and compliance.ResponsibilitiesLead and execute statistical programming activities by developing and validating datasets and Tables, Listings, and Figures (TLFs) to ensure high-quality deliverables for pivotal studies, as well as Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS) for oncology regulatory submissions.Drive end-to-end programming from SDTM through ADaM to TLF generation in compliance with CDISC standards and regulatory requirements.Develop SDTM CRF annotations and SDTM specifications, and analysis dataset specifications to ensure accurate implementation of SAPs and TLF shells; perform hands-on programming to create and validate SDTM and ADaM datasets and TLFs, ensuring quality, integrity, and submission readiness; conduct comprehensive reviews of submission data packages to ensure quality, completeness, and alignment with regulatory expectations.Manage and coordinate statistical programming activities for project planning and delivery to ensure high-quality outputs and adherence to timelines.Develop and manage programming timelines and resource plans; collaborate closely with Biostatistics, Data Management, and cross-functional teams to ensure efficient and accurate execution; manage the generation and tracking of datasets and TLFs for ongoing and completed studies; ensure appropriate data usage and high-quality outputs; proactively identify and resolve programming-related issues prior to database lock and analysis; maintain all required documentation in compliance with Trial Master File (TMF) requirements.For outsourced studies, oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met.Review and agree on vendor project timelines and resource planning; work in tandem with Biostatistics and Data Management members to ensure best vendor performance; monitor analysis dataset and TLF transfers for ongoing and complete trials; confirm data use and output quality; proactively ensure the resolution of programming-related issues prior to database lock and analysis; be accountable and verify completeness of study programming deliverables; maintain all required documentation for TMF.Maintain institutional knowledge across oncology compounds and support the development of standardized programming practices for datasets and TLFs to improve efficiency and quality.Contribute to CRF and SDTM standard development; support the development, implementation, and maintenance of Analysis Data Model (ADaM) datasets and TLF standards; support training initiatives to ensure consistent implementation of ADaM and TLF standards in clinical trial analyses.Provide programming support to prepare regulatory-requested analyses and help the submission team achieve quick turnaround in response to regulatory agencies.Develop TLFs to support submission-related QAs with quick turnaround timelines; support ad-hoc and exploratory analyses requested by clinical teams; provide programming support for regulatory responses and potential Advisory Committee meetings.Develop and maintain programming macros to effectively support internal data review and monitoring.Collaborate with Biostatistics team members to define requirements for efficacy data review; develop and enhance macros; support the internal data review and monitoring activities.QualificationsEducation QualificationsMaster's Degree in Biostatistics or a similar degree required.PhD in Biostatistics or a similar degree preferred.Experience Qualifications6+ years of proven experience within the pharmaceutical industry or CROs supporting statistical analysis of clinical trial programming, with a master's degree required.Oncology experience required.Advanced working knowledge of all aspects of the SAS programming language used in clinical trial programming.Advanced working knowledge of CDISC SDTM and ADaM, and extensive experience with their implementation in clinical trial analysis.Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials.Knowledge of all phases of drug development, including early and late phase clinical development and global submission.Experience with R and Python programming languages.Familiarity with AI/ML and their applications in clinical data analysis.Experience supporting and maintaining a statistical computing environment and clinical data repository system.Travel RequirementsAbility to travel up to 10% of the time.Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.Salary Range: USD$140,400.00 - USD$210,600.00J-18808-Ljbffr","datePosted":"2026-05-28T02:56:52.968Z","dateModified":"2026-05-28T02:56:52.968Z","hiringOrganization":{"@type":"Organization","name":"Initial Therapeutics","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Basking Ridge","addressRegion":"NJ","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"8253fa202c32baca420797db"},"url":"https://jobsearcher.com/jobs/8253fa202c32baca420797db"}}