Epidemiologist
Develop initial or update safety signal detection and management documents for global developmental and marketed products to support and enhance appropriate signal detection activities and robust safety evaluation
Review and/or develop relevant epidemiology sections and/or papers for relevant conferences and/or
peer-reviewed journals as assigned
Develop or support development of instruments for epidemiological assessment strategies and safety surveillance in coordination with Biostatistics
Participate in plan/design, execute or contribute to development of observational studies and interventional studies for assigned global developmental and marketed products
Develop epidemiological assessment and safety surveillance plan for assigned projects or studies
Review epidemiology data in supporting the development of risk management plan/risk evaluation
and mitigation strategies (REMS) and other safety related documents
Contribute to the design, implementation, and management of safety studies and clinical trials
Search and review epidemiological data and safety literature in supporting development of Ad hoc or regular safety submissions
Accountable for epidemiology sections of investigator’s brochures, risk management plans, aggregate safety reports (DSUR and PSUR), and responses to health agency’s inquiries for global development and post-marketing products
Perform safety data evaluation and risk assessment for assigned drug products
Provide or contribute to the materials used for Safety meetings including but not limited to the Clinical Safety Team, Data Monitoring Committee, Global Safety Data Monitoring Committee, Data and Safety Monitoring Board (DSMB)
Contribute epidemiology input to GST Working Group meetings, Signal Detection meetings and other Global Drug Safety and Evaluation Center (GDSEC) meetings as assigned
Performs other departmental duties as assigned
Qualifications
Education:
Graduate degree (PhD, MD, MS, MPH) in a relevant field is required:
Doctoral degree with at least 2 years of industry experience, academia, and/or regulatory agency
Master’s degree with 6+ years of experience in a national/local public health agency, regulatory agency, biopharma, and/or the medical device industry (including at least 1 to 2 years of biopharma or
medical device industry experience)
Professional Experience:
Experience and training in public health, pharmacy, health services research, health outcomes research, epidemiology, biostatistics or other relevant fields
Familiarity and experience with the development and implementation of epidemiology research strategies
Expertise in Biostatistics, Epidemiology/ secondary database analyses (e.g., claims, national survey data, etc.), Psychometrics
Demonstrated experience as a member of a product or project team
Experience in scientific writing of peer-reviewed, academic and/or public health literature
Familiarity with Drug Development and Phase 1-4 clinical trials
Knowledge and Skills:
Strong understanding of research methodology and statistics, as well as strong technical writing, and strong ability to critically review published scientific literature
Strong verbal and written communication, presentation skills, including experience
Critical thinking and problem-solving skills, ability to set priorities and develop strategies/studies to answer complex research questions
Experience managing multiple projects, often complex in nature and with both internal and external stakeholders under short timelines
Ability to analyze and interpret safety data
Good understanding of advanced design and analysis techniques used in the analysis of secondary data (e.g., matching, multivariate regression, meta-analysis, etc.)
Ability to conceptualize the presentation of results (e.g., develop layout of tables and figures for inclusion in analysis plans)
Working knowledge of 2 or more secondary database types (e.g., claims, surveys, electronic medical records)
Working knowledge/ability to use standard statistical packages (i.e. SAS, STATA, etc)
Ability to contribute to written processes to ensure consistent and quality deliverables
Additional Information
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: