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 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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. Job Summary:
Position leads Epidemiology activities and/or projects in support of new drug development and/or post-marketing drug safety for the marketed products. The epidemiologist is responsible for the design, conduct, analysis, and reporting of pharmacoepidemiologic research studies of assigned DSI products, for providing consultation on epidemiologic issues as needed, and lead the strategic plan for epidemiologic studies. This position provides epidemiologic expertise and deliverables for RMP/REMS, evaluation of safety signals, feasibility of Epidemiologic studies and/or safety surveillance, and advice for future studies in line with the product strategic plan. In collaboration with development team and/or clinical safety team, this position provides feedback in the clinical trial design, safety analysis plan, and propose more complex data analysis. This position also independently manages relationships with internal and external key stakeholders to conduct Epidemiologic studies and may provide recommendations to lower levels. This position solves complex technical problems and partnership/clientele issues related to epidemiologic studies with advanced experience and expertise. Finally, this position approves epidemiologic complex decisions for project teams and makes strategic decisions that impact more than one project team. This position independently manages the epidemiologic-related issues of the assigned product, and is able to lead meetings, discussions and propose new ways of working. Responsibilities:
Integration of Epidemiology into developmental process and post-marketing safety. The epidemiologist leads major project area, particularly designs and coordinates all aspects of epidemiologic research programs according to DS strategy and propose 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 methods, tools and data sources to ensure that projects represent current state of science, and maintains professional knowledge 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 sections and/or supporting documents independently. Reviews the documents within epidemiology and safety, and across functions. The epidemiologist directs risk management activities to ensure high quality and is able to respond regulatory queries and/or inspections. The epidemiologist leads the assessment, interpretation and communication of relevant scientific literature; summarizes epidemiologic data; determines own approach to tasks and independently applies basic and more complex 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 including generation of study proposals. 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.) including the supervision of ordering and shipping of all equipment and supplies for observational studies 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 delegation of certain tasks when possible.
Study feasibility: Independently evaluates external databases and/or other data sources including registries for study feasibility. Prepares the study feasibility reports. Reviews the study feasibility reports and propose new studies according to the product strategic plan.
Evaluation of safety signals: Triage of concerns including safety concerns, and proactively engages with team members. Makes recommendations for identification, assessment or management of safety signals. Conducts evaluation of safety signal independently. Reviews and presents the results.
Provides support to clinical team on clinical trial design and SAP, and other functions: Proactively works with other groups to identify epidemiologic research needs for projects, works interactively to develop research studies to address such needs, and propose new study designs or effective ways of working. The epidemiologist develops and validates new measurement techniques, including but not limited to new instruments for measurement of health-related quality of life; critiques internally and externally written manuscripts/published literature and, provides epidemiologic consultation on clinical trial design, SAP, and interpretation. Qualifications:
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education/Experience:
10 + Years’ experience in epidemiology preferred. 4 + Years in industry preferred. 7 + Years of experience in drug safety
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.
Clinical Study Design