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Design, Analysis and Evaluation of Confounding Bias Using RWD


  • Yuan-Li  Shen, DrPH

    Yuan-Li Shen, DrPH

    • Deputy Division Director, Division of Biometrics V, OB, OTS, CDER
    • FDA, United States

    Yuan-Li is the Deputy Division Director in Division of Biometrics V, Office of Biostatistics, Office of Translational Science, CDER, FDA. The teams that she is associated with support all statistical aspects of regulatory submissions in Gastrointestinal, Lung/Head and Neck, Neuro-oncology/Rare cancers/Solid Tumor, Pediatric Malignancies, Melanoma/Sarcoma products. She received a doctorate in Biostatistics from the University of North Carolina, Chapel Hill. She has over 25 years of combined experience in clinical trial setting across academia, pharmaceutical industry and FDA.

  • Yueqin  Zhao, PhD

    Yueqin Zhao, PhD

    • Lead Mathematical Statistician, OB, OTS, CDER
    • FDA, United States

    Yueqin Zhao is a lead mathematical statistician in Office of Biostatistics, Center for Drug Evaluation and Research, FDA. Her research interests include benefit-risk assessment, signal detection, and statistical methods in observational studies.

  • Michele  Jonsson Funk, PhD, FISPE

    Michele Jonsson Funk, PhD, FISPE

    • Associate Professor of Epidemiology; Director, Center for Pharmacoepidemiology
    • University of North Carolina at Chapel Hill, United States

    Dr Jonsson Funk is an Associate Professor of Epidemiology and Director of the Center for Pharmacoepidemiology at UNC. Her research focuses on improving methods for the study of drug safety and effectiveness using real world data including understanding the impact of measurement error in studies using claims and EHR data, methods for generalizing treatment effects from clinical trials to real world populations, and evaluating treatment effect heterogeneity. As principal investigator for the DETECTe Demonstration Project, she led a team that evaluated the performance of approaches to assessing and addressing the threat of unmeasured confounding. Dr Jonsson Funk has 120 peer-reviewed publications spanning multiple therapeutic areas.