Principal Research Epidemiologist - Pregnancy PASS

Senior Research Epidemiologist - Pregnancy PASS Truveta is the world’s first health provider led data platform with a vision of Saving Lives with Data. Our mission is to enable researchers to find cures faster, empower every clinician to be an expert, and help families make the most informed decisions about their care. Achieving Truveta’ s ambitious vision requires an incredible team of talented and inspired people with a special combination of health, software and big data experience who share our company values . Truveta was born in the Pacific Northwest, but we have employees who live across the country. Our team enjoys the flexibility of a hybrid model and working from anywhere. In person attendance is required at least once per year for an onsite meeting. For overall team productivity, we optimize meeting hours in the pacific time zone. We avoid scheduling recurring meetings that start after 3pm PT, however, ad hoc meetings occur between 8am-6pm Pacific time. #LI-remote Who We Need Truveta is rapidly building a talented and diverse team to tackle complex health and technical challenges. Beyond core capabilities, we are seeking problem solvers, passionate and collaborative teammates, and those willing to roll up their sleeves while making a difference. If you are interested in the opportunity to pursue purposeful work, join a mission-driven team, and build a rewarding career while having fun, Truveta may be the perfect fit for you. This Opportunity We are seeking an experienced Senior Research Epidemiologist to lead and execute high-quality, client-driven epidemiological and health services research. This role is responsible for the end-to-end delivery of real-world evidence studies supporting life sciences, healthcare, and regulatory decision-making. The ideal candidate brings strong pharmacoepidemiology and regulatory-facing research experience, with demonstrated involvement in post-authorization safety studies (PASS) and other post-marketing evidence generation. Experience conducting or supporting studies in special populations, particularly pregnancy or perinatal populations, is highly valued. This is a highly collaborative, client-facing role that combines methodological leadership, project execution, and scientific communication. Key Responsibilities Research Leadership Execution Lead and execute end-to-end epidemiological and real-world evidence studies, ensuring scientific rigor, transparency, and regulatory relevance. Design and oversee study protocols, statistical analysis plans (SAPs), study reports, and manuscripts, including post-authorization safety studies (PASS). Support or lead studies focused on drug safety in special populations, including pregnant people and neonatal outcomes, where applicable. Ensure research outputs are suitable for regulatory submissions, responses, and post-marketing commitments. Uphold best practices in study conduct, reporting, and Good Pharmacoepidemiology Practices (GPP). Methodological Analytical Excellence Apply advanced epidemiologic methods across study types such as: Post-authorization safety studies (PASS) Drug safety monitoring and pharmacovigilance Comparative effectiveness research Health Economics and Outcomes Research (HEOR) Disease surveillance and signal detection Collaborate closely with analytics and data science teams to review results, assess robustness, and interpret findings. Leverage or interpret outputs from surveillance and signal detection tools, including TreeScan, where applicable. Stay current with evolving regulatory guidance, observational research methods, and industry standards, including expectations for pregnancy safety evaluation. Project Management Serve as a primary research point of contact for customers, including life sciences partners and regulatory-focused stakeholders. Manage project timelines, resources, deliverables, and risks across multiple concurrent studies. Clearly communicate study design, methodolo ... (truncated, view full listing at source)