European Statistical Forum - Relatori

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. With the introduction of a new operating model at UCB Jens-Otto is curently holding the position of a BSO Lead Data & Innovation Analyst at UCB Biosciences GmbH.

Lisa has 25 years of experience in the clinical research environment. In her current role, Lisa is supporting the management of the biostatistics team including the development of professional growth, supervision of the quality of deliverables and outputs, as well as the oversight of processes for biostatistical activities to ensure they are up-to-date and aligned with the business need and regulatory requirements. Since Decembre 2025 she has been appointed in her company as Scientific Director contact for AIFA.
Lisa’s areas of expertise include DSMB support, submission studies, integrated summaries and contributing to Clinical Study Reports. She has worked in a variety of therapeutic areas and has particular expertise in respiratory, cardiovascular, oncology including rare diseases. She is a committee member of ESF (European Statistical Forum) and is also a member of several associations of biostatisticians. Lisa has been a contributing author on scientific articles in cardiology, diabetes and oncology.

Fabiola La Gamba is currently the full development lead statistician for the Neuroscience and Gene Therapy early development portfolio at Novartis. She joined Novartis in Basel (Switzerland) in 2020 as an Early Development Statistician and transitioned to Full Development within the Neuroscience Unit in 2022. Prior to Novartis, Fabiola worked at Johnson & Johnson in Beerse (Belgium) as a Preclinical Statistician, where she earned her Ph.D. in Bayesian Nonlinear Hierarchical Models with applications in pharmacometrics. Her doctoral research was part of the EU-funded Marie Curie Network project “IDEAS,” which focused on advancing statistical methods for early drug development.

Federica has extensive experience leading global biometrics strategies across the full drug development lifecycle. With over 20 years of experience in international pharmaceutical settings, she has led multidisciplinary teams across oncology, immunology and rare diseases, enabling data-driven decision-making and supporting regulatory submissions, late-phase development, and medical affairs.

Dr. phil. (PhD) Angelika Caputo, born on June 16, 1966, in Germany, holds German and Italian nationality and has two children. She completed her school education in 1985 and pursued studies in Statistics and Sociology at the University of Munich, Germany, earning a Diploma in Statistics and a PhD in Statistics. Professionally, she worked as a Research Assistant at the University of Munich from 1993 to 2000, then at the University Medical Center Freiburg until 2006, where she also coordinated a DFG Research Unit. She joined Novartis Pharma AG in Basel, Switzerland in 2007 where she is currently serving as a Global Program Biostatistics Head in the Neuroscience Development Unit.

Lukas Aguirre Davila, Dr. rer. nat., is an expert in biostatistics and trial design, working with clinical trials since 2013. He works as a regulator since 2019, when he joined PEI. Since 2023 he is an alternate member of the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA). He is a member of the Leadership Team of the Biostatistics Specialized Interest Area (SIA) of the Methodology Working Party (MWP) and member of the Biostatistics Operational Expert Group (BSOEG).

Guillemette de la Borderie has 18 years of experience as a statistician in several therapeutic areas (Cardiovascular, Central Nervous System Disorders, inflammatory disease, rare disease) from Phase I to Phase III in the pharmaceutical industry. She has been working for UCB since 2020 and supports statistical activities as project lead statistician in Late Development Statistics. She graduated in 2007 from ESSEC Business School and holds a master’s degree in Statistics in Public Health (MSc).

Yulia Dyachkova is working at Merck as an Associate Director Biostatistician. Yulia holds a Master degree in Biostatistics from University of British Columbia, Vancouver, Canada. She has over 25 years of experience working in biostatistics and 20 of them as a Project statistician in Pharma (Eli Lilly and Merck).
Yulia worked in several therapeutic areas: pulmonary, cardiovascular disease, neuroscience and most extensively in oncology. Yulia has led all aspects of statistical launch activities in a broad variety of global markets including responsibility in HTA, RWE, generating and interpreting real world evidence, designing phase IV studies. She has been involved as author/co-author of many manuscripts, including those related to single arm trials, published in medical and statistical peer review journals.

Since January 2010 Tim Friede is Professor of Biostatistics at the University Medical Center Göttingen where he heads up the Department of Medical Statistics. He graduated in Mathematics from the University of Karlsruhe and obtained his PhD from the Faculty of Medicine at the University of Heidelberg. In 2001 he joined the Department of Mathematics and Statistics at Lancaster University as NHS Training Fellow in Medical Statistics and was later promoted to Lecturer in Biostatistics. From 2004 on he worked for Novartis Pharma AG, Basel before joining Warwick Medical School as Associate Professor of Medical Statistics in October 2006. Tim Friede’s methodological research interests are in clinical biostatistics including designs for clinical trials (in particular flexible adaptive designs) and generalized evidence synthesis (including systematic reviews and meta-analyses) as well as applications in rare diseases and cardiovascular medicine. Tim Friede is author of more than 450 publications on methodology and applications of statistics in peer-reviewed journals, including applications in clinical medicine published in NEJM, Lancet, JAMA and Nature Medicine.

Prof dr. Wolfgang Jacquet has a master degree in Mathematics and Operational research from the Vrije Universiteit Brussels (VUB). After a first period in academics he was senior business consultant in industry to rejoin academics in 2002. In 2009 he obtained the degree of  Doctor of Philosophy (Ph.D.) in Mathematics and Computer Science (VUB). Throughout his career he became actively engaged in educational research and the design of experiments. He was researcher at the University of Antwerp and the University of Antwerp.

At present prof dr. Wolfgang Jacquet is affiliated with the Faculty Medicine & Pharmacy (VUB) and with the faculty of Psychology and Education of the VUB. He is bio-statistics area coordinator for the Belgian Federal Agency for Medicines and Health Products (FAMHP), and member of the Methodology Working Party (MWP) of the European Medicine Agency (EMA). He is co-founder of the research unit Localities Ontologies Commons Integrated (LOCI) of the Faculty of Psychology and Educational Sciences (VUB). His major scientific interest are education, the application of statistics and the development of measurements systems both from a practical and a theoretical point of view.

Giles is a Consultant statistician at working at Phastar since 2021 working with biotech and pharmaceutical companies to design clinical trials especially in early phase or rare disease trials with a specialty in Bayesian methods. Beforehand he was a predoctoral fellow at Imperial CTU working on Bayesian methods for small population/rare disease trials.

Rudradev Sengupta is a biostatistician with a PhD in Statistics from UHasselt (Belgium) and over 10 years of experience in pharmaceutical research, mainly at Johnson & Johnson. He has strong expertise in statistical modeling and advanced analytical methods applied to clinical trial design and analysis. He is also involved in academic teaching at UHasselt.

Andrew is the owner and lead consultant of Regnitio, a methodology and regulatory consultancy firm he founded in 2025 after an 18-year career as a regulator. He trained as a statistician, and joined the UK regulator as a statistical assessor in 2007. After rising to senior assessor, he moved over to the post-licensing side as Head of Epidemiology, and in 2014 he moved on again to the European Medicines Agency, working in many functions but always with a statistical focus. Key responsibilities included being the Regulatory Chair for ICH E11A and ICH E6 Annex 2, as well as the main scientific secretariat for EMA’s Methodology Working Party. He has been involved in the assessment of many hundreds of development programmes, including Scientific Advice, Marketing Authorisation, PIPs, and Orphan Significant Benefit decisions.

Giulia is a principal biostatistician and has nine years of clinical research experience. Her responsibilities include preparation of statistical analysis plans, provision of statistical input into the design and review of protocols and Case Report Forms (CRFs), preparation of statistical reports and presentation of results, as well as creation of SAS programs for validation of datasets and tables, listings, and figures (TLFs). Giulia has experience across all phases of clinical development. Her therapeutic experience includes oncology, respiratory, dermatology, rare disease, and CNS. She is also experienced with ISS preparation and analysis. She has excellent knowledge of statistical software including SAS, R and STATA, as well as industry guidelines including ICH and good clinical practice (GCP). Giulia holds a bachelor’s degree from the University of Bologna, which included a tenure at the University of Glasgow, UK, along with a master’s degree in statistical science from the University of Bologna, which included completing her thesis at the University of Chicago.