Esri
Senior Director, Epidemiology Analytics
Esri, Township of Bernards, New Jersey, United States,
Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary
Position leads Epidemiology data analysis activities and/or projects in support of new drug development and/or post-marketing drug safety for the marketed products. This position is responsible for the design and implementation of a statistical analysis plan (SAP), reporting pharmacoepidemiologic research studies of DSI products, providing consultation on data analysis issues as needed, and leading the strategic analysis plan for epidemiologic studies. This position provides epidemiologic expertise and advice for future studies in line with the product strategic analysis plan. In collaboration with the development team and/or clinical safety team, this position provides feedback on the clinical trial design, and statistical analysis plan, and proposes more complex data analysis. This position also independently manages relationships with internal and external key stakeholders to conduct SAP and may provide recommendations to lower levels. This position solves complex technical problems and partnership/clientele issues related to data analysis with advanced experience and expertise. Finally, this position approves complex statistical analysis decisions for project teams and makes strategic decisions that impact more than one project team. This position independently manages the statistical-related issues of DS products and can lead meetings, discussions, and propose new ways of data analysis. This position leads the strategic analysis plan and provides mentorship to statisticians, programmers, fellows, and other DS personnel. This position manages direct reports.Responsibilities
Integration of epidemiologic analytic strategies into developmental and post-marketing activities. This position leads major project area, particularly strategic study designs, and data analysis, coordinates all aspects of epidemiologic research programs according to DS strategy, and proposes new study design and/or statistical analysis as needed. Prepares reports to communicate epidemiologic study results to DSI management, internal committees, external investigators, and regulatory agencies. Collaborates with other groups at DSI in preparing documentation for regulatory agencies, reimbursement agencies, or other organizations. Maintains awareness of new statistical methods, tools, and data sources to ensure that projects represent the current state of science and maintains professional knowledge and up-to-date statistical methods by reading scientific journals, attending internal and external courses, and undertaking methodological research. Contributes to the scientific literature in the form of manuscripts and publications. Presents at professional scientific meetings, teaches courses, collaborates with external investigators, and communicates with scientific personnel at regulatory agencies. Participates in training new department members and/or mentoring fellows or other DS colleagues as needed.RMP/REMS: Primarily responsible for drafting the related statistical sections and/or supporting documents independently. Reviews the documents within epidemiology and safety, and across functions. This position participates in the study design and SAP for REMS, PASS, or PMS commitments. This position responds to regulatory queries and/or inspections. This position leads the assessment and quantitative analysis of the scientific literature; summarizes epidemiologic data; determines own approach to tasks and independently applies basic and more complex analytic techniques; recognizes when additional statistical and programming consultation is needed and communicates requirements effectively; maintains awareness of internal and external data resources and identifies appropriate studies for addressing questions of interest, recognizing the limitations and strengths of various design options; provides consultation to other groups on the validity of observational studies, independently performs data queries and summarizes epidemiologic information in a tabular and graphical form and communicates impactful research to support the development of RMP/REMS of DS products.Epidemiologic studies and/or safety surveillance program: Leads the study design and statistical analysis of interventional and noninterventional studies including the generation of study protocols and SAP. Drafts/reviews the study concept/protocols particularly the study design and/or statistical analysis plan. Leads the execution of pharmacoepidemiologic studies and projects (e.g., observational studies, registries, etc.) when needed; directs design and preparation of data collection forms and data tabulations; drafts data summaries/reports of epidemiologic studies for regulatory submissions; drafts/reviews publications and technical reports with a delegation of certain tasks when possible.Study feasibility: Independently analyzes external databases and/or other data sources including registries for study feasibility. Prepares the study feasibility reports. Reviews the study feasibility reports and proposes new studies according to the product strategic plan.Evaluation of safety signals: Leads new methods for safety data analysis from interventional and noninterventional studies including artificial intelligence.Proactively engages with team members. Makes recommendations for quantitative assessment of safety signals. Conducts quantitative evaluation of safety signals independently. Reviews and presents the results.Provides support to clinical team on clinical trial design, particularly SAP: Proactively works with other groups to identify epidemiologic data analysis needs for projects, works interactively to develop research studies to address such needs, and proposes new study designs or effective ways of working. Provides epidemiologic consultation on clinical trial design, SAP, and interpretation.Qualifications
Successful candidates will be able to meet the qualifications below with or without reasonable accommodation.Education Qualifications (from an accredited college or university)
Ph.D. in Statistics, mathematics, or engineering is required.Advanced SAS programming skills (SAS certification)Experience Qualifications
10 or More Years of experience in statistics4 or More Years in the pharmaceutical industry7 or More Years of experience in drug safety data analysis and/or signal evaluation preferredExperience in oncology data analysis preferredExperience with direct reportsDaiichi 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.
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Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary
Position leads Epidemiology data analysis activities and/or projects in support of new drug development and/or post-marketing drug safety for the marketed products. This position is responsible for the design and implementation of a statistical analysis plan (SAP), reporting pharmacoepidemiologic research studies of DSI products, providing consultation on data analysis issues as needed, and leading the strategic analysis plan for epidemiologic studies. This position provides epidemiologic expertise and advice for future studies in line with the product strategic analysis plan. In collaboration with the development team and/or clinical safety team, this position provides feedback on the clinical trial design, and statistical analysis plan, and proposes more complex data analysis. This position also independently manages relationships with internal and external key stakeholders to conduct SAP and may provide recommendations to lower levels. This position solves complex technical problems and partnership/clientele issues related to data analysis with advanced experience and expertise. Finally, this position approves complex statistical analysis decisions for project teams and makes strategic decisions that impact more than one project team. This position independently manages the statistical-related issues of DS products and can lead meetings, discussions, and propose new ways of data analysis. This position leads the strategic analysis plan and provides mentorship to statisticians, programmers, fellows, and other DS personnel. This position manages direct reports.Responsibilities
Integration of epidemiologic analytic strategies into developmental and post-marketing activities. This position leads major project area, particularly strategic study designs, and data analysis, coordinates all aspects of epidemiologic research programs according to DS strategy, and proposes new study design and/or statistical analysis as needed. Prepares reports to communicate epidemiologic study results to DSI management, internal committees, external investigators, and regulatory agencies. Collaborates with other groups at DSI in preparing documentation for regulatory agencies, reimbursement agencies, or other organizations. Maintains awareness of new statistical methods, tools, and data sources to ensure that projects represent the current state of science and maintains professional knowledge and up-to-date statistical methods by reading scientific journals, attending internal and external courses, and undertaking methodological research. Contributes to the scientific literature in the form of manuscripts and publications. Presents at professional scientific meetings, teaches courses, collaborates with external investigators, and communicates with scientific personnel at regulatory agencies. Participates in training new department members and/or mentoring fellows or other DS colleagues as needed.RMP/REMS: Primarily responsible for drafting the related statistical sections and/or supporting documents independently. Reviews the documents within epidemiology and safety, and across functions. This position participates in the study design and SAP for REMS, PASS, or PMS commitments. This position responds to regulatory queries and/or inspections. This position leads the assessment and quantitative analysis of the scientific literature; summarizes epidemiologic data; determines own approach to tasks and independently applies basic and more complex analytic techniques; recognizes when additional statistical and programming consultation is needed and communicates requirements effectively; maintains awareness of internal and external data resources and identifies appropriate studies for addressing questions of interest, recognizing the limitations and strengths of various design options; provides consultation to other groups on the validity of observational studies, independently performs data queries and summarizes epidemiologic information in a tabular and graphical form and communicates impactful research to support the development of RMP/REMS of DS products.Epidemiologic studies and/or safety surveillance program: Leads the study design and statistical analysis of interventional and noninterventional studies including the generation of study protocols and SAP. Drafts/reviews the study concept/protocols particularly the study design and/or statistical analysis plan. Leads the execution of pharmacoepidemiologic studies and projects (e.g., observational studies, registries, etc.) when needed; directs design and preparation of data collection forms and data tabulations; drafts data summaries/reports of epidemiologic studies for regulatory submissions; drafts/reviews publications and technical reports with a delegation of certain tasks when possible.Study feasibility: Independently analyzes external databases and/or other data sources including registries for study feasibility. Prepares the study feasibility reports. Reviews the study feasibility reports and proposes new studies according to the product strategic plan.Evaluation of safety signals: Leads new methods for safety data analysis from interventional and noninterventional studies including artificial intelligence.Proactively engages with team members. Makes recommendations for quantitative assessment of safety signals. Conducts quantitative evaluation of safety signals independently. Reviews and presents the results.Provides support to clinical team on clinical trial design, particularly SAP: Proactively works with other groups to identify epidemiologic data analysis needs for projects, works interactively to develop research studies to address such needs, and proposes new study designs or effective ways of working. Provides epidemiologic consultation on clinical trial design, SAP, and interpretation.Qualifications
Successful candidates will be able to meet the qualifications below with or without reasonable accommodation.Education Qualifications (from an accredited college or university)
Ph.D. in Statistics, mathematics, or engineering is required.Advanced SAS programming skills (SAS certification)Experience Qualifications
10 or More Years of experience in statistics4 or More Years in the pharmaceutical industry7 or More Years of experience in drug safety data analysis and/or signal evaluation preferredExperience in oncology data analysis preferredExperience with direct reportsDaiichi 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.
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