Session 1: Causal inference in randomized studies
November 22, 2025 | 8:30 a.m. to 1:00 p.m.
Keynote:
Appropriate implementation of the estimands framework in clinical trials
Gregory Levin, PhD, Associate Director for Statistical Science and Policy, Office of Biostatistics, Food and Drug Administration
BREAK
Speakers:
Exploring causal inference methods for clinical trials
Florian Lasch, PhD, Biostatistics Specialist, European Medicines Agency
Unveiling estimands: potential, pitfalls, perspective
Mouna Akacha, PhD, Group Head of Statistical Methodology, Novartis
Assessing spillover effects among staff in implementation interventions
Alisa J. Stephens Shields, PhD, Associate Professor of Biostatistics in Biostatistics and Epidemiology, Hospital of the University of Pennsylvania
BREAK
Panel Discussion:
- Moderator: Janet Wittes, PhD, Consultant
- Panelists:
- Gregory Levin, PhD, Associate Director for Statistical Science and Policy, Office of Biostatistics, Food and Drug Administration
- Dan Scharfstein, ScD, Chief of the Division of Biostatistics, Department of Population Health Sciences, University of Utah School of Medicine
- Kelley Branch, MD, PhD, Professor of Medicine and Associate Director Clinical Trials Service Unit, University of Washington
- Qing Liu, PhD, Senior Director, Design and Innovation, Amgen
Session Chair:
Andrea Rotnitzky, PhD, Professor of Biostatistics, University of Washington School of Public Health
Session 2: Causal inference in observational studies
November 23, 2025 | 8:30 a.m. to 1:00 p.m.
Keynote:
Evidence triangulation in dementia research
Maria Glymour, SD, Chair and Professor, Department of Epidemiology, Boston University
Speakers:
Assessing vaccine effectiveness in observational studies via nested trial emulation
Michael Hudgens, PhD, Professor and Chair, Department of Biostatistics, University of North Carolina Chapel Hill
Evaluating the impact of longitudinal treatment strategies when patients are informatively monitored, with application to ventilation strategies for intensive care patients
Ruth Keogh, PhD, Professor of Biostatistics and Epidemiology, Medical Statistics Department; Co-Director, Centre for Data and Statistics Science for Health, London School of Hygiene and Tropical Medicine
Leah Pirondini, PhD, Department of Medical Statistics, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine
Strategies for enhancing transparency and interpretability of findings from clinical studies
Susan Gruber, PhD, MPH, MS, Co-Founder, TL Revolution
BREAK
Panel Discussion:
- Moderator: Steven R. Cole, PhD, Cary C. Boshamer Distinguished Professor, Department of Epidemiology, University of North Carolina Chapel Hill)
- Panelists:
- Maria Glymour, SD, Chair and Professor, Department of Epidemiology, Boston University
- James M. Robins, MD, Mitchell L. and Robin LaFoley Dong Professor of Epidemiology, Harvard T.H. Chan School of Public Health
- Susan Gruber, PhD, MPH, MS, Co-Founder, TL Revolution
Session Chair:
Andrea Rotnitzky, PhD, Professor of Biostatistics, University of Washington School of Public Health
Session 3: Data fusion in causal inference
November 24, 2025 | 8:30 a.m. to 1:00 p.m.
Keynote:
Unlocking the potential of EHR data for real-world evidence: opportunities and challenges
Tianxi Cai, ScD, Professor of Biomedical Informatics, Harvard Medical School; John Rock Professor of Population and Translational Data Sciences, Harvard T.H. Chan School of Public Health
Speakers:
Causal approaches for hybrid randomized clinical trials with longitudinal outcomes
Jiawen Zhu, PhD, Senior Principal Statistical Scientist, Genentech
Integrating diverse evidence sources in clinical research: causal inference at the intersection of trials and real-world evidence
Shu Yang, PhD, Professor of Statistics, North Carolina State University
Trial augmentation using external data and foundation models
Issa Dahabreh, MD, MS, ScD, Associate Professor of Epidemiology, Harvard T.H. Chan School of Public Health
BREAK
Panel Discussion
- Moderator: Dan Scharfstein, ScD, Chief of the Division of Biostatistics, Department of Population Health Sciences, University of Utah School of Medicine
- Panelists:
- Issa Dahabreh, MD, MS, ScD, Associate Professor of Epidemiology, Harvard T.H. Chan School of Public Health
- Hana Lee, PhD, Senior Staff Fellow, Food and Drug Administration
- Antonio Remiro Azócar, PhD, Statistical Innovation Leader, Novo Nordisk
Session Chair:
Alex Luedtke, PhD, Faculty, Department of Health Care Policy, Harvard Medical School
Session 4: Causal inference: past, present and future
November 25, 2025 | 8:30 a.m. to 1:00 p.m.
Keynote:
Fortified Proximal Causal Inference with many imperfect negative controls
Eric Tchetgen Tchetgen, PhD, Professor of Biostatistics, Biostatistics and Epidemiology; Professor of Statistics and Data Science; The Wharton School, University of Pennsylvania.
Speakers:
Inferential replicability for online decision-making algorithms
Susan A. Murphy, PhD, Mallinckrodt Professor of Statistics and of Computer Science; Associate Faculty, Kempner Institute; Harvard University
Outcomes trials in diabetes and obesity – casual inference needed?
Henrik Ravn, PhD, Senior Statistical Director, Novo Nordisk
Causal AI for clinical care: deep causal behavioral policy learning
Maya Petersen, PhD, Professor, Epidemiology and Biostatistics, University of California Berkeley
BREAK
Panel Discussion
- Moderator: Andrea Rotnitzky, PhD, Professor of Biostatistics, University of Washington School of Public Health
- Panelists:
- Eric Tchetgen Tchetgen, PhD, Professor of Biostatistics, Biostatistics and Epidemiology; Professor of Statistics and Data Science; The Wharton School, University of Pennsylvania
- Mark van der Laan, PhD, Professor, Biostatistics and Statistics, University of California, Berkeley
- Elizabeth A. Stuart, PhD, AM, Chair and Professor, Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health
Session Chair:
Alex Luedtke, PhD, Faculty, Department of Health Care Policy, Harvard Medical School