Scientific Committee Organizing Committee

  Rodolphe THIEBAUT, Bordeaux University, Chair Frédéric DUBOIS, Servier, Chair
  Mouna AKACHA, Novartis Sophie GUILLONNEAU, Sanofi, Co-chair
  Nicky BEST, GSK Alexia LETIERCE, QualityStat, Treasurer
  Anne-Laure BOULESTEIX, Munich University Chantal DIN-BELL, Sanofi, Co-treasurer
  Antoine CHAMBAZ, Paris University David DELVART, Excelya, Webmaster
  Frank E HARRELL Jr, Vanderbilt University Nadia GAUDEL-DEDIEU, Sanofi
  Geert MOLENBERGHS, Hasselt University Fabienne MEURICE, Ewentis
  Marie-Karelle RIVIERE, Sanofi Philippe SAINT-PIERRE, Toulouse University
  Bart SPIESSENS, Janssen Anne THIEBAUT, Inserm
  Pascale TUBERT-BITTER, Inserm Michel VAILLANT, LIH
Laurence WATIER, Inserm
Pr. Rodolphe THIEBAUT

Pr. Rodolphe THIEBAUT
Rodolphe Thiebaut is a medical doctor, with specialization in Public Health. He holds a PhD in Biostatistics from Bordeaux University.

He started his research carrier at the Institut National de Sante et de la Recherche Medicale (INSERM) as a research scientist between 2002 and 2009 and as research director between 2010 and 2013. He has been a research fellow in the Immunobiology Division of the Institute of Child Health (London, UK) in 2007.

He is now Professor in Public Health / Biostatistics at the University of Bordeaux. He leads a research group (SISTM - Statistics in Systems Biology and Translational Medicine) devoted to the modelling and analysis of high-dimensional data mainly applied to immunology through the French Vaccine Research Institute (http://www.vaccine-research-institute.fr/en/). This group, which is embedded in the INSERM U1219 Research Centre (http://www.bordeaux-populationhealth.center/), has been recognized as an INRIA project team since January 2015 (http://www.inria.fr/equipes/sistm). Its translational research starts with immunological questions and ends with the development of statistical methods for the collection and analysis of high-dimensional datasets generated in this domain. He is in charge of the medical information department of the Bordeaux University Hospital.

He is also the Director of the Department of research in Public Health of the Bordeaux University, the deputy director of the INSERM U1219 Research Centre (11 research teams) and the Director of the Graduate School of Digital Public Health, coordinator of the Master of Public Health Data Science at ISPED (Institut de Santé Publique d’Epidémiologie et de Dévelopement).

He is the author/coauthor of more than 300 publications in peer-reviewed journals including the New England Journal of Medicine, Lancet, AIDS, Journal of Immunology, Biometrics, Biostatistics, Statistics in Medicine, Plos Computational Biology.
Pr. Anne-Laure BOULESTEIX

Anne-Laure BOULESTEIX
Anne-Laure Boulesteix is a statistician with focus on medical statistics, computational statistics and metascience. She holds diploma degrees from the Ecole Centrale Paris (engineering) and University of Stuttgart (mathematics) and a PhD in statistics (2005) from the University of Munich. After working as a post-doc in medical statistics at the Medical School of the Technical University of Munich and at the Sylvia Lawry Centre for Multiple Sclerosis Research e.V., she was appointed as an assistant professor in 2009 at the Medical School of the University of Munich, where she is now associate professor since 2012.

She leads the research group “Biometry in Molecular Medicine” and is additionally associate member of the Department of Statistics at the Faculty of Mathematics, Computer Science and Statistics of the University of Munich. Her research interests include prediction modelling, molecular data analysis and metascience (“research on research methodology”). She is board member of the university-wide “Open Science Center”, member of the steering group of the international STRATOS initiative (“STRengthening Analytical Thinking for Observational Studies”) and chair of the STRATOS simulation panel.

She authored more than 100 articles both in statistical and biomedical international peer-reviewed journals (e.g., Biometrics, Statistics in Medicine, The American Statistician, Bioinformatics, Briefings in Bioinformatics, PLOS Computational Biology), which were cited more than 4200 times according to the Web of Science, including 2000 citations for papers as first and last author.
Marie-Karelle RIVIERE

Marie-Karelle RIVIERE
Marie-Karelle Rivière did her PhD on early phases clinical trials in oncology in collaboration with Servier and INSERM. She worked on “Adaptive dose-finding designs in oncology for combination of molecules and molecularly targeted agents”. During her post-doc in pharmacometrics with Pr. France Mentré, she participated in the European project IDEAL where she worked on the estimation of the Fisher information matrix for non-linear mixed effect models with different types of outcomes.

She currently belongs to the Statistical Methodology Group in Sanofi. She is mainly involved on oncology topics. Her main research interests are: Bayesian designs, early phases designs in oncology including PK/PD information, enrichment designs, basket/platform designs, and subgroups identification.
Pr. Frank E HARRELL Jr

Frank E Harrell Jr
Dr. Harrell received his PhD in Biostatistics from the University of North Carolina in 1979. He was on the faculty of Duke University for 17 years and of the University of Virginia for 7 years. He founded the Division of Biostatistics and Epidemiology at the University of Virginia School of Medicine in 1996 and the Department of Biostatistics at Vanderbilt University in 2003. He has taught biostatistics and research methodology to hundreds of physicians since 1980 and has been a mentor or co-mentor to several physician investigators. He is an Associate Editor for Statistics in Medicine, a member of Faculty of 1000 Medicine, and a member of the Scientific Advisory Board for Science Translational Medicine. His specialties are development of accurate prognostic and diagnostic models, model validation, clinical trials, observational clinical research, technology evaluation, quantifying predictive accuracy, missing data imputation, clinical trials, pharmaceutical safety, flexible Bayesian design and analysis, and statistical graphics and reporting. He has worked on a large number of clinical trials.

Dr. Harrell is a Fellow of the American Statistical Association and winner of its 2014 WJ Dixon Award for Excellence in Statistical Consulting. He was the 2008 Mitchell Lecturer for the Department of Statistics, Glasgow University. He was the 2012 Presidential Invited Lecturer for WNAR, International Biometric Society, the 2017 Visionary Speaker, Clinical Studies Coordinating Center, University of North Carolina Department of Biostatistics, Chapel Hill, and the 2018 Distinguished Visiting Scientist, University of Calgary Biostatistics Centre. He is an FDA Expert Statistical Advisor and was a member of the NIH Biostatistical Methods and Research Design Study Section. He is the associate director of the Research Methods program for the Vanderbilt NIH CTSA and was the director of the Statistics and Methodology Core for the Vanderbilt Kennedy Center for Research on Human Development. He is the PI of the NHLBI multinational ISCHEMIA trial DSMB statistical center.

He is the author of two of the most highly cited papers (both are on development of prognostic models) in the history of Statistics in Medicine and has almost 300 peer-reviewed publications (5 with >1000 citations).
Bart SPIESSENS

Bart SPIESSENS
Bart Spiessens is Senior Scientific Director, Biostatistics within the Infectious Diseases and Vaccines Therapeutic Area at Janssen R&D. He is leading a statistical group, responsible for several viral and bacterial vaccines clinical trials, including the Ebola, ExPEC (Extraintestinal Pathogenic E. coli) and RSV (Respiratory Syncytial Virus) vaccines. He joined Janssen in 2016 from GlaxoSmithKline Vaccines where he started in 2003 as statistician working on the Malaria and HPV (Human Papilloma Virus) vaccine projects. In 2007, he became responsible for the different cancer immunotherapeutic trials.

Bart holds a PhD in Science (Biostatistics) from the Katholieke Universiteit Leuven (Belgium) on group sequential methods for generalised linear mixed models. He also has a M.Sc. in Biostatistics from the University of Hasselt.

His interests focus on clinical trials, vaccine development, interim analyses, validation of biomarkers and subgroup analyses.
Pascale TUBERT-BITTER

Pascale TUBERT-BITTER
Pascale Tubert-Bitter is Director of Research at the French National Institute of Health and Medical Research (Inserm) and head of the research team “High-Dimensional Biostatistics for Drug Safety and Genomics” at the Inserm – University Paris-Saclay Research Center in Population health (U1018). She previously headed the Inserm research unit « Biostatistics, Biomathematics, Pharmacoepidemiology and Infectious Diseases ». She has a PhD in Mathematics from the Pierre and Marie Curie University in Paris. Her research interests concern the statistical methods to assess treatment effects, mainly in areas pertaining to adverse drug reaction risks: automated signal detection from large pharmacovigilance databases, methodological issues raised by medico-administrative data in pharmacoepidemiology and benefit-risk ratio analyses, in particular for vaccines. She has responsibilities in research training (MS of biostatistics, PhD school council, Paris-Saclay University). Pascale Tubert-Bitter is also involved in public health expertise, in particular with the French Medicines Agency (ANSM), and currently member of the Scientific Committee of EPI-PHARE, the public expertise group in epidemiology of health products (ANSM - French Social Security organization). She is also Secretary of the French Region of the International Biometric Society (IBS) since 2015, current member and former Chair of the IBS-Education Committee, and elected member since 2006 of the Biopharmacy and Health Group board of the French Statistical Society.
Geert MOLENBERGHS

Geert MOLENBERGHS
Geert Molenberghs is Professor of Biostatistics at the Universiteit Hasselt and KU Leuven in Belgium. He received the B.S. degree in mathematics (1988) and a Ph.D. in biostatistics (1993) from the Universiteit Antwerpen. Dr Molenberghs published methodological work on surrogate markers in clinical trials, categorical data, longitudinal data analysis, and on the analysis of non-response in clinical and epidemiological studies. He served as Joint Editor for Applied Statistics, Co-editor for Biometrics, Co-editor for Biostatistics, Series Editor of Wiley Probability & Statistics, and Wiley StatsRef. He acted and acts as Associate Editor for several journals and undertook numerous refereeing tasks (for journals, faculty member promotion, faculty member appointments, etc.). He was President of the International Biometric Society. He was elected Fellow of the American Statistical Association and received the Guy Medal in Bronze from the Royal Statistical Society. He has held visiting positions at the Harvard School of Public Health (Boston, MA). He is founding director of the Center for Statistics at Hasselt University and currently the director of the Interuniversity Institute for Biostatistics and statistical Bioinformatics, I-BioStat, a joint initiative of the Hasselt and Leuven universities. He published, as editor and author of several books on longitudinal data analysis, possibly subject to missingness (with Geert Verbeke) and surrogate endpoints. He has (co-)taught nearly 200 short and longer courses on the topic in universities as well as industry, in Europe, North America, Latin America, and Australia. He received research funding from FWO, IWT, the EU (FP7), U.S. NIH, U.S. NSF, UHasselt, and KU Leuven. He is member of the Belgian Royal Academy of Medicine.
Antoine CHAMBAZ

Antoine CHAMBAZ
Antoine Chambaz is professor of statistics at Université de Paris, a member of MAP5 (UMR CNRS 8145) and the head of its Statistics team. He is also the director of FP2M (FR CNRS 2036), the Parisian Federation of Mathematical Modelling.

Antoine Chambaz holds a PhD in mathematics (2003) from the René Descartes University. His main research interest is in theoretical, computational and applied statistics, and in causality. In particular, he contributes to the development and application of the targeted learning methodology, with a focus on applications to medicine and precision medicine, and studies problems at the intersection of statistics and machine learning.

Antoine Chambaz coedits the International Journal of Biostatistics.
Nicky BEST

Nicky BEST
Nicky Best is currently Head of Advanced Biostatistics and Data Analytics at GlaxoSmithKline (GSK), where she leads a team of UK- and US-based statisticians who help drive methodological innovation to enhance the efficiency of clinical trial design, analysis and decision-making strategies. Her work includes embedding the use of prior elicitation, assurance (probability of success) and quantitative decision making strategies into GSK’s drug development process; implementing Bayesian dynamic borrowing methods for formal re-use of historical data in the analysis of new clinical trials and advocating for their use with regulatory agencies; providing training and consultancy on the implementation of the new ICH E9 estimands framework; and providing technical and strategic support for use of digital technologies (e.g. wearables) in clinical trials. She was awarded the RSS/PSI award for Statistical Excellence in the Pharmaceutical Industry in 2015 for her role in implementing prior elicitation and statistical assurance to improve decision making in clinical development. In 2018 she received the RSS Bradford Hill Medal for her work on Bayesian methods in clinical trials, cost-effectiveness, epidemiology and drug development. She currently co-chairs the EFSPI/PSI Historical Data SIG and is a member of the Transcelerate Placebo and Standard of Care Data Sharing workstream.

Prior to joining GSK in 2014, Nicky was an academic statistician at the Medical Research Council Biostatistics Unit in Cambridge and at Imperial College London, where she was professor of Statistics and Epidemiology. She is well known for her work in applied Bayesian statistics in the fields of health and social science, and as a co-developer of the WinBUGS Bayesian software, and has over 100 peer-reviewed publications. She was editor of the RSS Series A journal for several years, and was also a statistical expert witness in some high-profile Government Inquiries in the UK.
Mouna AKACHA

Mouna AKACHA
Mouna Akacha is .