Summittherapeutics
Sr. Manager, Statistical Programming
Summittherapeutics, Menlo Park, California, United States, 94029
Job Title: Sr. Manager, Statistical Programming
Department: Data Programming
Overview of Role:The Senior Manager, Statistical Programming will be responsible for leading and managing the statistical programming activities for clinical trial data collection, analysis, reporting, and visualization, with a primary focus on oncology studies. This role will oversee the development and implementation of statistical programming strategies, manage a team of statistical programmers, and collaborate closely with cross-functional teams to ensure high-quality deliverables that meet regulatory requirements and support drug development efforts.Role and Responsibilities:Lead and manage statistical programmers, providing mentorship, technical guidance, and career development opportunities.Develop and implement statistical programming strategies and best practices for clinical trials across all phases, ensuring alignment with company goals, industry standards, and regulatory requirements.Oversee the creation and validation of CDISC-compliant SDTM and ADaM datasets, with a focus on oncology-specific data structures and endpoints.Collaborate with Biostatistics to implement complex statistical analyses for oncology trials, including time-to-event analyses, response evaluations, and biomarker assessments.Direct the development of tables, listings, and figures (TLFs) for clinical study reports, regulatory submissions (including NDA/BLA), and publications.Ensure compliance with FDA, EMA, PMDA and other regulatory agency requirements for statistical programming deliverables in submissions.Lead the development and maintenance of standardized oncology-specific analysis datasets, programs, and macros to improve efficiency and consistency across projects.Manage resource allocation, project timelines, and deliverables for multiple studies simultaneously, including outsourced work to CROs.Serve as the statistical programming representative in cross-functional study teams and external collaborations.Contribute to the development and improvement of department SOPs, working instructions, and quality control processes.Stay current with evolving trends in oncology clinical trials, statistical methodologies, and programming techniques, and implement innovative approaches as appropriate.Contribute to regulatory interactions and represent statistical programming in regulatory meetings when needed.Experience, Education and Specialized Knowledge and Skills:Master’s degree in Statistics, Biostatistics, Computer Science, or a related field.Minimum 10 years of experience in statistical programming within the pharmaceutical/biotech industry, with at least 5 years focused on oncology trials and 3+ years in a leadership role.Extensive experience with CDISC standards (SDTM, ADaM, define.xml) and their application in clinical studies across all phases.Strong proficiency in SAS programming, including macro development, ODS graphics, and experience with SAS/STAT procedures.In-depth knowledge of oncology-specific endpoints, such as progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and RECIST criteria.Experience with statistical analysis methods commonly used in oncology trials, including time-to-event analyses, and methods for handling missing data.Thorough understanding of regulatory requirements for statistical programming in submissions to FDA, EMA, PMDA, and other health authorities.Experience in preparing and reviewing key documents for regulatory submissions (e.g., SAP, ADaM spec, Define files, Reviewer’s Guide).Demonstrated experience in leading and managing statistical programming teams, including experience with global and/or outsourced teams.Strong project management skills, with the ability to prioritize and manage multiple studies simultaneously.Excellent problem-solving skills and the ability to provide innovative solutions to complex programming challenges in clinical research.Strong communication skills, both written and verbal, with the ability to effectively communicate technical concepts to non-technical stakeholders.Experience with R and Python programming languages is highly desirable.Familiarity with data standards organizations (e.g., CDISC, PhUSE) and industry initiatives.Preferred Qualifications:Experience with oncology immunotherapy trials and associated efficacy endpoints (e.g., iRECIST).Knowledge of electronic data capture (EDC) systems and clinical data management processes.Experience with data visualization tools (e.g., R Shiny, Spotfire, Tableau).Familiarity with cloud-based computing environments and big data technologies.Active participation in industry conferences and working groups.
#J-18808-Ljbffr
Department: Data Programming
Overview of Role:The Senior Manager, Statistical Programming will be responsible for leading and managing the statistical programming activities for clinical trial data collection, analysis, reporting, and visualization, with a primary focus on oncology studies. This role will oversee the development and implementation of statistical programming strategies, manage a team of statistical programmers, and collaborate closely with cross-functional teams to ensure high-quality deliverables that meet regulatory requirements and support drug development efforts.Role and Responsibilities:Lead and manage statistical programmers, providing mentorship, technical guidance, and career development opportunities.Develop and implement statistical programming strategies and best practices for clinical trials across all phases, ensuring alignment with company goals, industry standards, and regulatory requirements.Oversee the creation and validation of CDISC-compliant SDTM and ADaM datasets, with a focus on oncology-specific data structures and endpoints.Collaborate with Biostatistics to implement complex statistical analyses for oncology trials, including time-to-event analyses, response evaluations, and biomarker assessments.Direct the development of tables, listings, and figures (TLFs) for clinical study reports, regulatory submissions (including NDA/BLA), and publications.Ensure compliance with FDA, EMA, PMDA and other regulatory agency requirements for statistical programming deliverables in submissions.Lead the development and maintenance of standardized oncology-specific analysis datasets, programs, and macros to improve efficiency and consistency across projects.Manage resource allocation, project timelines, and deliverables for multiple studies simultaneously, including outsourced work to CROs.Serve as the statistical programming representative in cross-functional study teams and external collaborations.Contribute to the development and improvement of department SOPs, working instructions, and quality control processes.Stay current with evolving trends in oncology clinical trials, statistical methodologies, and programming techniques, and implement innovative approaches as appropriate.Contribute to regulatory interactions and represent statistical programming in regulatory meetings when needed.Experience, Education and Specialized Knowledge and Skills:Master’s degree in Statistics, Biostatistics, Computer Science, or a related field.Minimum 10 years of experience in statistical programming within the pharmaceutical/biotech industry, with at least 5 years focused on oncology trials and 3+ years in a leadership role.Extensive experience with CDISC standards (SDTM, ADaM, define.xml) and their application in clinical studies across all phases.Strong proficiency in SAS programming, including macro development, ODS graphics, and experience with SAS/STAT procedures.In-depth knowledge of oncology-specific endpoints, such as progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and RECIST criteria.Experience with statistical analysis methods commonly used in oncology trials, including time-to-event analyses, and methods for handling missing data.Thorough understanding of regulatory requirements for statistical programming in submissions to FDA, EMA, PMDA, and other health authorities.Experience in preparing and reviewing key documents for regulatory submissions (e.g., SAP, ADaM spec, Define files, Reviewer’s Guide).Demonstrated experience in leading and managing statistical programming teams, including experience with global and/or outsourced teams.Strong project management skills, with the ability to prioritize and manage multiple studies simultaneously.Excellent problem-solving skills and the ability to provide innovative solutions to complex programming challenges in clinical research.Strong communication skills, both written and verbal, with the ability to effectively communicate technical concepts to non-technical stakeholders.Experience with R and Python programming languages is highly desirable.Familiarity with data standards organizations (e.g., CDISC, PhUSE) and industry initiatives.Preferred Qualifications:Experience with oncology immunotherapy trials and associated efficacy endpoints (e.g., iRECIST).Knowledge of electronic data capture (EDC) systems and clinical data management processes.Experience with data visualization tools (e.g., R Shiny, Spotfire, Tableau).Familiarity with cloud-based computing environments and big data technologies.Active participation in industry conferences and working groups.
#J-18808-Ljbffr