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. Currently Jens-Otto is holding the position of a BSO 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 supporting the management of the biostatistics team including the development 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. 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, 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.

Fabiola La Gamba is a Senior Principal Statistician with over seven years of experience in the pharmaceutical industry. She joined Novartis (Basel, Switzerland) in 2020 as an Early Development Statistician and transitioned to Full Development in the Neuroscience Unit by 2022. Prior to joining Novartis, Fabiola worked at Johnson & Johnson (Beerse, Belgium) as a Preclinical Statistician, where she earned a Ph.D. in Bayesian Nonlinear Hierarchical Models with applications on pharmacometrics. Her PhD project was part of the Eu-funded Marie Curie Network exploring statistical methods for early drug development: “IDEAS”.

Dr Victoria Strauss is TAM Chapter Head, Global Biostatistics & Data Science in Boehringer-Ingelheim, and a honorary research in University of Oxford.She specifies in real world evidence methodology including incorporating real world evidence methodology into clinical trials, propensity score, trial emulation, bias minimization in real world data. Prior to join BI, she was the lead Statistician in pharamaco and device epidemiology research group in Centre for Statistics in Medicine, University of Oxford. She is a faculty member of “ISPE pre-conference course: machine learning ” and was a co-lead in the UK NIHR routine data SIG.

Biography available soon

Chrissie is the Vice President and Head for Speciality & Primary Care Statistics at GSK. She leads a group of statisticians supporting the development of new and approved medicines in respiratory, immunology, hepatology, infectious diseases, neuroscience, renal, HIV, and global health. Chrissie also leads a group of statisticians based in India supporting the R&D portfolio. Chrissie has worked in the Pharmaceutical Industry for more than 30 years and she has experience of developing and commercialising new medicines in a variety of clinical disease areas across all phases of clinical development.

Chrissie is actively engaged in statistical societies, pharmaceutical trade associations and initiatives relating to the Pharmaceutical Industry. Chrissie leads the EFSPI Statistics Leaders Forum, she is a member of the EFPIA Clinical Research Expert Group where she co-leads the Innovation in Clinical Trials team and she co-leads the EFPIA/EFSPI estimand implementation working group (ICH E9(R1)).

In 2019 Chrissie was given honorary membership for her outstanding service to PSI, and she was selected for the Women in Data “Twenty in Data and Technology” award which showcases phenomenal women who encompass every level of seniority and data discipline, and who continue to make role models visible within their industry professions.

Chrissie is a Chartered Statistician of the Royal Statistical Society (RSS). Chrissie has an MSc in Applied Statistics and a BSc (Hons) in Statistics with Management Science Techniques.

Benjamin Hofner is Head of Data Science and Methods at the Paul-Ehrlich-Institut (PEI). In this role he is involved in the assessment of Clinical Trial Applications and Marketing Authorisation Applications, and provides Scientific Advice to stakeholders. He is member of the EMA Methodology Working Party ESEC, member of the leadership team of the EMA Specialized Interest Area on Biostatistics, and Adjunct Lecturer for Biostatistics at the medical school at FAU Erlangen-Nuremberg. Benjamin was involved in the IMI project EU-PEARL on patient centric research platforms as regulatory task lead and is member of the temporary drafting group (tDG) for the EMA reflection paper on platform trials.

Karin brings over 15 years of experience as a Biostatistician, with a primary focus on early clinical development. She earned her diploma in Mathematics from the University of Heidelberg in 2003 and completed her PhD in Biostatistics at the University of Goettingen in 2006.

At Novartis in Basel, Karin leads the biostatistics and pharmacometric modeling teams for early clinical development in Global Health and Skeletal Diseases. Throughout her tenure at Novartis, she has worked across various therapeutic areas, gaining particular expertise in respiratory disease and immunology, as well as infectious and skeletal diseases. Karin is also an expert in evaluating cardiac safety risks.

A key focus of her professional work is utilizing question-based approaches to streamline clinical development, especially in statistical analyses and reporting.

Tobias Mielke works since 2018 as internal statistical consultant on anything related to innovative and adaptive study designs at Johnson & Johnson. In his role at Johnson & Johnson, he collaborates closely with internal drug development teams across multiple therapeutic areas, as well as externally as representative in Cross-Pharmaceutical and Multi-Stakeholder initiatives, such as IMI EU-PEARL and the EFPSI Methods Leaders group. Tobias joined Johnson & Johnson from ICON Clinical Research, where he was one of the software architects of ADDPLAN DF, a software for the design and analysis of adaptive dose-finding trials using MCPMod. Tobias holds a PhD on the topic of study design optimization for nonlinear mixed effects models from University of Magdeburg. In his free time, Tobias is playing the Trumpet, attempts to play Piano and enjoys running.

Luke is a Senior Statistician at AstraZeneca (UK), working with the Oncology Payer biometrics and statistical innovation teams. Besides this, his main research interests are in statistical methodology development for innovative trial design – adaptive designs, umbrella trials, basket trials, platform trials – especially using Bayesian methods. He is keen on developing collaborations to work on interesting statistical problems.

Biography available soon

Biography available soon

Dr Haiyan Zheng is a Reader in Statistics at the University of Bath. Haiyan received a prestigious Marie Skłodowska-Curie ITN fellowship to conduct her PhD research at Lancaster University (2015-2018). She then worked at Newcastle University and The MRC Biostatistics Unit in Cambridge before joining Bath in Sep 2023.

Haiyan leads a team focused on developing advanced statistical methods for small population clinical trials, with notable research projects including STEEP, IDENT, and SEER-NTA. Her research interests encompass adaptive trial designs, Bayesian methods, finite mixture distributions, and precision medicine.