Alex Secora

About Alex Secora

I am an epidemiologist and biostatistician with extensive research experience conducting pharmacoepidemiology and health economics and outcomes research (HEOR) studies, alongside regulatory experience as an epidemiologist at the Food and Drug Administration (FDA). I earned my doctorate in epidemiology at Johns Hopkins University, where my research focused on potentially inappropriate medication use among patients with heart failure, including modeling adverse event risk across the spectrum of renal function and evaluating the downstream clinical and economic consequences of medication-related harm. During my 9+ years in FDA’s Office of Surveillance and Epidemiology (OSE), I reviewed and conducted post-market drug safety and effectiveness studies, contributing to the agency’s pharmacovigilance efforts and supporting regulatory decision-making through real-world evidence (RWE). I am currently the Associate Director of Epidemiology in IQVIA\'s Information and Analytics, Government Solutions team, where I lead research, data strategy, and technical solutioning for government clients. My work includes the design and oversight of real-world data (RWD) studies, development of RWE platforms and infrastructure, and integration of HEOR methodologies to assess drug effectiveness, safety, and cost-effectiveness in healthcare data. I also serve as IQVIA’s lead scientist and co-principal investigator on FDA’s Biologics Effectiveness and Safety (BEST) initiative, where I support FDA by providing access to robust data sources, scalable analytics, and subject matter expertise in pharmacoepidemiology, medical informatics, and distributed data networks. My work has been published in numerous scientific journals, and I co-authored a chapter in Strom’s Pharmacoepidemiology, Sixth Edition (2020).

Experience

1. Associate Director, Epidemiology

   IQVIA

   Jul 2021 — Present · Falls Church, VA, US

   Provides expertise in electronic healthcare databases (e.g, administrative claims and electronic health records) and data management/quality standards, common data models and distributed networks, advanced analytics and technology solutions (e.g, RWE platforms, AI/ML, and NLP), advanced statistical and epidemiological methods, and HEOR research to government clients• Designs, manages, and implements pharmacoepidemiology, HEOR, comparative effectiveness, drug safety, and other related large-scale database studies• Leads IQVIA’s science and data team as co-principal investigator of the BEST initiative, FDA’s active surveillance system for vaccine and blood products using federated network of databases• Leads research data optimization efforts for IQVIA administrative claims and electronic health record data assets in the Observational Medical Outcomes Partnership (OMOP) common data model • Leads HEOR, RWD, analytics, and technical proposal development and solutioning for federal procurements and contracts• Supports strategic business development and leads initiatives to grow Information and Analytics and RWD business lines within IQVIA Government Solutions• Manages team of epidemiologists, biostatisticians, outcomes researchers, and project management staff

Education

• New York University

  Bachelor's degree, Psychology

  2000 — 2004

• The Johns Hopkins University

  Master of Public Health (MPH), Epidemiology/Biostatistics

  2011 — 2012

• The Johns Hopkins University

  Doctor of Philosophy (Ph.D.), Epidemiology

  2015 — 2019