European Statistical Forum - Speakers

Jens-Otto received a diploma in Mathematics in 1993. In 1994 he started his career in Biostatistics at Grünenthal GmbH in Aachen. Here he worked in several therapeutical areas like gynecology and pain. Later on he became a specialist in the Phase 1 area. In 2005 he started to UCB (legacy Schwarz Pharma) as a Project Biostatistician in Phase 1. With the restructuring at UCB in 2008 Jens-Otto became the Head EU Biostatistics supervising Biostatisticians located in Monheim (Germany) and Brussels. Since 2016 he is also the Head of the East Asia Biostatistics of UCB. UCB’s key indications are CNS and immunology. From 2017 to 2019  Jens-Otto was the Head of Statistical Sciences – Bone & New Diseases at UCB Biosciences GmbH. Currently Jens-Otto is holding the position of a SSI Business Operations Excellence Senior Lead at UCB Biosciences GmbH. 

Lisa has over 20 years of experience in the clinical research industry. In her current role, Lisa is responsible for the management of the biostatistics team including the development professional growth, supervision of the quality of deliverables and outputs, as well as the management of processes for biostatistical activities to ensure they are up-to-date and aligned with the business need and regulatory requirements. Lisa’s areas of expertise include DSMB support, submission studies, integrated summaries, writing Statistical Analysis Plans and contributing to Clinical Study Reports. She has worked in a variety of therapeutic areas and has particular expertise in respiratory, cardiovascular, infectious diseases and oncology. She is a committee member of ESF (European Statistical Forum) and is also a member of several associations including PSI (Statisticians in the Pharmaceutical Industry) and EFSPI (European Federation of Statisticians of the Pharmaceutical Industry). Lisa has been a contributing author on scientific articles in cardiology, diabetes and oncology.

After the degree in statistical sciences from the University of Florence (1998), Giacomo stared his career in drug development in Menarini where he was exposed to different therapeutic areas and development phases. In 2007 he moved to Geneva to join Merck Serono, where he led a biostatistical team dedicated to early development in oncology. In 2013 Giacomo joined Grunenthal as global head of Biostatistics. In 2016 he moved to medical device industry in Livanova as Global Head of Data Management and Statistics. In 2020 he joined Daiichi-Sankyo as Head of Biostatistcs and Data Management Europe. Since 2011 he is part of the scientific board of European Statistical Forum; since 2013 he is part of the European Statistical Leader group of EFSPI. His main research interests are in the field of Bayesian statistics, adaptive design and applications of data science techniques to drug development.

Marc Vandemeulebroecke joined Novartis in 2006, coming from Schering AG in Berlin. He has been supporting development programs in early and late phase development across various disease areas (incl. Neuroscience, Gastrointestinal, Parasitology, Cardio-metabolic, Immunology, Transplant and Hepatology) as statistician and pharmacometrician. Currently he is Global Group Head for Dermatology. Marc holds a maîtrise in mathematics from the University Paris XI, a diploma in mathematics from the University of Münster, a PhD in mathematical statistics from the University of Magdeburg, and an MSc in PKPD modeling from the University of Manchester. He received the Gustav-Adolf-Lienert award from the German Region of the International Biometric Society (IBS) for his PhD thesis, which focused on adaptive designs. He co-authored various scientific publications and one R package and is Associate Editor of Pharmaceutical Statistics. Marc’s current interests include statistical graphics and machine learning.

Prof Alonso obtained master degrees in Mathematics and Biostatistics from the universities of Havana (Cuba) and Hasselt (Belgium) in 1997 and 1999, respectively. In 2004, he received his Phd degree in Biostatistics from Hasselt University in Belgium. Prof Alonso has worked as a consultant at the National Coordination Center for Clinical Trials in Cuba, as Assistant  Professor at the University of Maastricht in the Netherlands and as Associate Professor at the KU Leuven in Belgium. He has published methodological research on the  validation of surrogate markers, the assessment of rating scales and inference under misspecification in hierarchical models. He is also a coauthor of the freely available R package Surrogate that implements several validation strategies for surrogate  endpoints, within the  causal-inference and meta-analytic frameworks

Jonathan Bartlett is a Reader in Statistics at the University of Bath, UK, having held previous positions at AstraZeneca’s Statistical Innovation Group and the London School of Hygiene & Tropical Medicine. His research focuses on developing statistical methods for handling missing data and more recently on estimation of estimands in clinical trials. He maintains a statistics blog at https://thestatsgeek.com

Björn Bornkamp works in the Statistical Methodology Group of the Advanced Methodology and Data Science team at Novartis in Basel, where he provides consulting to statisticians and clinical teams on topics related to dose-finding studies, subgroup analyses, Bayesian statistics as well as estimands and causal inference.

Theodor studied statistics at the Dortmund University of Technology and at the University of Auckland. He joined the Institute of Biostatistics at Hannover Medical School in 2009 where his main areas of work were consulting, teaching and clinical trials. He also served as a deputy member for the Ethics Committee at Hannover Medical School and completed a PhD in Biostatistics. Theodor works as a Seconded National Expert at the EMA since September 2020.

After beeing a Professor of Statistics and Machine Learning at Ecole Polytechnique (IPP, institut Polytechnique de Paris) and a visiting researcher at Google Brain Paris, Julie Josse has just joined Inria as a senior researcher to set up a team in data-sciences for health. Julie Josse’s is an expert in handling missing values and has created a platform to collect works and give resources to users. Her curent research focuses on causal inferences techniques for personalized medicine. She leads a project with the Traumabase group dedicated to the management of polytraumatized patients. Julie Josse is dedicated to reproducible research with the R statistical software: she has developed packages including FactoMineR  to transfer her work, she is a member of the R foundation and of Rforwards to increase the participation of minorities in the community.

Fabrizia Mealli is Professor of Statistics. Her research focuses on causal inference, program evaluation, estimation techniques, simulation methods, missing data, and Bayesian inference, with applications to the social and biomedical sciences. She held visiting positions at Harvard University, UCLA, LISER Luxembourg. She serves as coordinator of the Statistics track for the PhD program in Mathematics, Computer Science, Statistics of the University of Florence, and sits the Steering Committee of the European Causal Inference Meeting. She is Elected Fellow of the American Statistical Association, and currently an associate editor of “The Annals of Applied Statistics” and “Observational Studies”.

Baldur is a Global Group Head in Early Development Analytics at Novartis, leading a team that provides biostatistics support in non-clinical, digital, and exploratory biomarkers. Previous roles at Novartis include project statistician in early clinical development and consultant in the Advanced Methodology and Data Science team. Baldur has been involved in several methodological initiatives, focusing on topics such as visualization, dose finding, historical data, and causal inference. Baldur holds a PhD in statistics from Cornell University.

CBP has a PhD degree in mathematical statistics specializing in Survival analysis.
He is currently working as statistical methodology advisor at LEO Pharma A/S. Before joining LEO cbp has worked as Associate Professor of Biostatistics at University of Copenhagen for almost 10 years, doing research within survival analysis, causal inference, adaptive designs, and multiple testing.
He is Adjungated professor of Biostatistics at University of Southern Denmark, Associate Editor of International Journal of Biostatistics, member of the Estimand implementation working group under EFPSI, and a board member of the Danish Society of Theoretical Statistics.