Invited speakers

INVITED SPEAKERS

Andrea Callegaro is Director of Biostatistics at GSK Vaccines in Belgium, bringing nearly 20 years of experience as a biostatistician. Since 2013, he has been dedicated to driving statistical innovation in vaccine clinical trials. Andrea is part of the Statistics & Data Science Innovation Hub (SDSIH), led by Nicky Best. He is also an invited professor at both KUL and Milano Bicocca, where he teaches courses on biomarker clinical trials. In addition, he serves as an administrator for the Quetelet Society (IBS Belgium). His research interests are centered on vaccine clinical trials, adaptive biomarker designs, surrogate endpoints (correlates of protection), and causal inference.

Fanny Chevalier is an associate professor in computer science and statistics at the University of Toronto; bestowed Knight of the Order of Academic Palms by the French Government. Prior to joining UofT, she was a research scientist at Inria, France. Prof. Chevalier’s research interests lie in Human-Computer Interaction and Information Visualization in the broad sense. She has published over 80 articles in the top venues in the areas of Human-Computer Interaction (ACM CHI, ACM UIST) and Visualization (IEEE Infovis, IEEE VAST, IEEE TVCG), more than a dozen of which received nominations and awards for best paper. Her work on supporting the authoring of animated graphics was selected by Apple as the best iPad app of the year 2016. She has also consistently served in both the organizing and technical program committees for the top-tier venues in her field for the past decades – most recently, she served as the doctoral symposium chair for ACM UIST 2019, as the program chair for ACM UIST 2020 and ACM ISS 2020, and as the Awards chair for ACM CHI 2022.

Kit Roes is Professor of Biostatistics at Radboud University Medical Center Nijmegen (Netherlands). He is chair of the Methodology Working Party of the European Medicines Agency, and senior expert at the Dutch Medicines Evaluation Board. His research focus is design and analysis of clinical trials, with an emphasis on innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He is currently involved as work package lead in multiple Horizon Europe funded projects that aim to improve clinical research for regulatory decision making. He serves on multiple Data Monitoring Committees. His experience includes over 25 years in clinical research in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.

Daniel Sabanés Bové studied statistics at LMU Munich, Germany and obtained his PhD at the University of Zurich, Switzerland in 2013 for his research work on Bayesian model selection. He started his career in Roche as a biostatistician for 5 years, then continued at Google as a data scientist for 2 years, before rejoining Roche as a statistical software engineering lead for 4 years. In 2024, Daniel co-founded RCONIS (Research Consulting and Innovative Solutions). He is (co-)author of multiple R packages published on CRAN and Bioconductor, as well as the book “Likelihood and Bayesian Inference: With Applications in Biology and Medicine”. He is currently a co-chair of the openstatsware working group on Software Engineering in Biostatistics.

Nigel Stallard is Director of Warwick Clinical Trials Unit and Professor of Medical Statistics at Warwick Medical School in the UK.  He has a first degree in Mathematics from the University of Cambridge and an MSc and PhD in Applied Statistics from the University of Reading, where he worked for ten years until moving to Warwick Medical School in 2005.  His primary research interests are in the statistical design and analysis of clinical trials. In particular, he has worked on optimal design for clinical trials in rare diseases and small populations and on methodology for trials with interim analyses and adaptations such as treatment or subgroup selection, funded by the Medical Research Council, National Institute of Health and Care Research and European Union.  He has published over 200 peer reviewed articles in methodological and medical journals and is an Editor-in-Chief of the journal Statistics in Medicine.

Mia Tackney (she/her) is a Research Associate at the MRC-Biostatistics Unit, University of Cambridge, working with Dr. Sofía Villar. Her research interests are in statistical methods for digital outcome measures in clinical trials and, in particular, methods for handling missing data.

 Jack Talboys is a software developer at Novartis. He graduated from the University of Bath with a BSc in Statistics in 2020. Since then, he spent 4 years working as a Data Scientist for a data consultancy, building R and python-based tools to help companies in a wide range of industries. In April of 2024 he joined the Open-source enablement team within Novartis as a Software Developer. In this role he has worked closely with study teams to help implement improved coding practices, as well as producing R packages and shiny applications to help study teams do their best work as efficiently as possible. He is interested in helping study teams utilise Open-source and contributing back to Open-source himself.

Simon Wandel holds a Master in Statistics and a PhD in Medical Statistics/Epidemiology, both from University of Bern. Since joining Novartis in 2010, he has worked in several disease areas both in early and late phase development. Currently, he is a Global Group Head in Advanced Quantitative Sciences in the Cardio-Renal-Metabolic Development Unit at Novartis. He is also co-chair of the EFSPI/PSI Special Interest Group “Historical Data”. Simon has a broad interest in statistics (with a slight bias towards Bayesian approaches) and is particularly interested in bringing novel statistical concepts in clinical trials to life.

Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He holds a PhD in Physics from the TU Darmstadt and joined Novartis 10+ years ago. He has worked extensively on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development.

Lukas Widmer is an Associate Director Statistical Consultant in the Advanced Methodology and Data Science group at Novartis. He holds a Doctor of Science degree from the Department of Biosystems, Science and Engineering at ETH Zürich, with a background in Computer Science and Computational Biology. Lukas joined Novartis over five years ago and focuses on developing, implementing, and collaborating on innovative statistical methods for clinical projects. He also creates trainings for statisticians and data scientists and provides consulting services. His research interests include safety modeling in oncology dose escalation, Bayesian statistics, data reuse through analysis results data modeling, genetic engineering, high-performance computing, and statistical software engineering.

Beate Wieseler is Head of the Department of Drug Assessment at the German Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG), Germany’s Health Technology Assessment agency. At IQWiG she is responsible for the scientific assessment of pharmaceuticals, the development of assessment methods as well as in the Institute’s collaboration with German and international external parties. Currently, Beate Wieseler also is the Chair of the Methodological and Procedural Guidance Subgroup of the European HTA Coordination Group. Prior to joining IQWiG in 2005, Beate Wieseler worked in clinical research and regulatory affairs for about 10 years. Beate Wieseler holds a Diploma in Biology from the University of Bonn and a Dr. rer. nat. from the University of Freiburg, Germany.