Senior Manager, Epidemiology

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Conduct or outsource literature reviews to gather epidemiological data on disease incidence, prevalence, mortality, natural history, demographics, co-morbidities, treatment patterns, and concomitant medications.

• Contribute epidemiological data to regulatory submissions that support Clinical Development Programs and other initiatives requiring such data.

• Provide initial patient funnel data for forecasting and commercial objectives.

• Identify suitable US and EU secondary data sources, including administrative claims and EMR databases.

• Lead Requests for Proposals and Statements of Work for outsourced epidemiological studies.

• Support multi-disciplinary non-interventional Phase IV study teams and oversee study-related regulatory submissions.

• Collaborate with project biostatisticians to develop statistical analysis plans.

• Manage external investigators, project managers, and operational leads at CROs and Data Providers.

• Communicate with US and EU Regulatory Leads concerning submission deliverables and PMR/PMC timelines.

• Build partnerships with stakeholders in Clinical Development, Medical Affairs, Biostatistics, and Regulatory Affairs.

• Share study plans, timelines, budgets, progress reports, and study outcomes with internal teams.

• Present research findings at scientific congresses and co-author manuscripts for peer-reviewed journals.

• Ensure adherence to relevant laws, regulations, and regulatory guidelines.

⛳️ Requirements

• Advanced degree (MS, MPH, MSPH, or PhD) in epidemiology or a related field (health services research, outcomes research, public health, pharmaceutical sciences).

• Minimum of 2 years of experience in the pharmaceutical industry, CRO, or academia.

• Experience with studies focused on rare diseases.

• Project management experience in planning, budgeting, resourcing, and executing the operational tasks necessary to complete a research study.

• Proven ability to successfully coordinate cross-functional processes.

• Experience in analyzing secondary data sources (administrative claims and EMR databases).

• Exceptional oral and written communication skills in English.

• Strong understanding of epidemiology and biostatistics.

• Experience in managing multiple projects and adjusting priorities as needed.

• Ability to work remotely with minimal supervision.

• Proficient in MS Word, Excel, and PowerPoint.

• Willingness to travel approximately 10% of the time.

• Therapeutic area experience in oncology; strong familiarity with SEER data and the SEER*Stat platform.

• Experience with site-based data collection in non-interventional studies (prospective patient registries and retrospective chart reviews).

• Experience in conducting post-marketing safety studies of marketed medicines.

• Background in supporting Clinical Drug Development, Safety, Forecasting, and Medical Affairs teams within a biopharmaceutical company.

• Experience in authoring protocols, study reports, and epidemiology sections of RMPs for regulatory submissions to the FDA, EMA, and other health authorities.

• Data analysis programming skills (SAS, Stata, R) or recent hands-on experience with 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.