Senior Manager, Epidemiology
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Job Description
Senior Epidemiology Manager leading pharmacoepidemiology studies and regulatory submissions for Jazz Pharmaceuticals’ biopharma pipeline. Supporting rare-disease research, secondary-data analysis, and cross-functional R&D programs.
Responsibilities:
- Conduct or outsource literature searches to identify epidemiology data on disease incidence, prevalence, mortality, natural history, demographics, co-morbidities, treatment patterns and concomitant medications
- Contribute epidemiology data to regulatory submissions supporting Clinical Development Programs and other processes requiring epidemiological data
- Provide top of the patient funnel data for forecasting and commercial purposes
- Identify appropriate US and EU secondary data sources, including administrative claims and EMR databases
- Lead Requests for Proposal and Statements of Work for outsourced epidemiology studies
- Support multi-disciplinary non-interventional Phase IV study teams and deliver study-related regulatory submissions
- Develop statistical analysis plans with project biostatisticians
- Manage external investigators, project managers and operational leads at CROs and Data Providers
- Communicate with US and EU Regulatory Leads regarding submission deliverables and PMR/PMC timelines
- Develop partnerships with Clinical Development, Medical Affairs, Biostatistics and Regulatory Affairs stakeholders
- Communicate study plans, timelines, budgets, progress reports and study results to internal teams
- Present research findings at scientific congresses and co-author peer-reviewed manuscripts
- Ensure compliance with applicable laws, regulations and regulatory guidelines
Requirements:
- Advanced degree (MS, MPH, MSPH, or PhD) in epidemiology or a related discipline (health services research, outcomes research, public health, pharmaceutical sciences)
- At least 2 years of experience in the pharmaceutical industry, CRO or in academia
- Experience with rare disease studies
- Project management experience in planning, budgeting, resourcing and executing the operational tasks required to complete a research study
- Experience successfully coordinating cross-functional processes
- Experience analyzing secondary data sources (administrative claims and EMR databases)
- Excellent oral and written communication skills in English
- Solid understanding of epidemiology and biostatistics
- Experience managing multiple projects and reprioritizing work when necessary
- Capable of working remotely with minimal supervision
- Proficiency with MS Word, Excel and PowerPoint
- Ability to travel approximately 10% time
- Therapeutic area experience in oncology; strong knowledge of SEER data and use of SEER*Stat platform
- Experience with site-based data collection in non-interventional studies (prospective patient registries and retrospective chart reviews)
- Experience conducting post-marketing safety studies of marketed medicines
- Experience supporting Clinical Drug Development, Safety, Forecasting and Medical Affairs teams within a biopharmaceutical company
- Experience authoring protocols, study reports, and epidemiology sections of RMPs for regulatory submissions to FDA, EMA and other health authorities
- Data analysis programming skills (SAS, Stata, R) or recent hands-on experience using an RWE platform technology
Benefits:
- Discretionary annual cash bonus or incentive compensation
- Discretionary equity grants
- Medical insurance
- Dental insurance
- Vision insurance
- 401k retirement savings plan
- Flexible paid vacation
- Remote work arrangement
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