Speakers

Invited Speakers

Kert Viele

Kert Viele is the Director of Research at Berry Consultants. He is a leader in Bayesian adaptive clinical trial methodology, with expertise in platform and basket trials as well as clinical trials incorporating the use of historical information. Dr. Viele is a Fellow of the American Statistical Association and has authored over 70 peer reviewed papers and developed over 100 custom Bayesian adaptive clinical trials for clients in industry, government, and academia. A former editor of the journal Bayesian Analysis, Dr. Viele is also an author of FACTS (Fixed and Adaptive Clinical Trial Simulator), clinical trial simulation software currently licensed to multiple pharmaceutical, academic, and government organizations.

Thomas Jaki

Thomas is an MRC Investigator (Programme Leader) at the MRC Biostatistics Unit in the Effiecient Study Design theme, and is also Chair for Computational Statstics at the University of Regensburg. He is also the President of the International Society for Clinical Biostatistics .

Thomas' research interests include adaptive designs and treatment effect heterogeneity, experimental design, sample size determination, statistical tests and confidence intervals. Thomas has significantly contributed to platform studies, including his work during the COVID-19 pandemic on the RECOVERY Trial.

Julie Marsh

Julie is an experienced statistical consultant who worked in the pharmaceutical industry for many years before returning to academia. She teaches statistics at the University of Western Australia and is a Senior Research Fellow at The Kids, Perth, where she specialises in adaptive clinical trials, statistical methods for detecting adverse events following immunisation and the longitudinal analysis of birth cohorts.

Thomas Snelling

Tom is the Director of Health and Clinical Analytics in the School of Public Health at the University of Sydney, and an infectious diseases physician in the Sydney Children’s Hospital Network. Tom is pioneering in the application of novel approaches to the design, coordination, implementation and analysis of public interest studies, and is successfully leading a suite of multi-institutional collaborative learning health projects across Australia. Working with a range of collaborative research groups across diverse clinical domain areas, these include Bayesian adaptive studies to improve the treatment and prevention of severe gastroenteritis in remote Aboriginal children, the primary prevention of food allergies in children, SMS text messages to improve timeliness of routine immunisation, and the management of cystic fibrosis.

Charlie McLeod

Charlie is an Infectious Diseases Paediatrician, post-doctoral researcher and recent recipient of a RAINE clinical research fellowship (2021-24) with emergent expertise in patient-centred research and novel clinical trial methodology.

She is a Deputy Head at the Wesfarmers Centre of Vaccines and Infectious Diseases, based at The Kids Research Institute Australia, and of a member of the Centre's Infectious Diseases Implementation Research (IDIR) team.

James Matcham

James is Vice President of Innovative Statistics at Cytel, where he focuses on applying advanced statistical methods to clinical development and regulatory decision-making. He brings over 30 years of experience, including key roles at Amgen and AstraZeneca, where he led statistical strategies for global regulatory and reimbursement submissions. His work has supported the approval of numerous biotechnology products in the US and EU. James specializes in adaptive trial design, Bayesian methods, and quantitative frameworks that support evidence-based regulatory decisions.

Hannah Johns

Hannah is a biostatistician at the University of Melbourne and Melbourne Medical school focused on innovative statistical approaches and trial designs in stroke research. She brings expertise in both traditional and machine learning methods, supporting a wide range of clinical studies. Hannah plays a key role in implementing adaptive randomisation in stroke trials and contributes statistical software to the R community. She also serves on the executive committee of the Australasian Stroke Trials Network.

Chris Selman

Chris is a postdoctoral biostatistician in the Clinical Epidemiology and Biostatistics Unit (CEBU), within the Murdoch Children's Research Institute (MCRI).

He completed his Master of Biostatistics from University of Melbourne in 2021 and finished a PhD in Biostatistics in 2025, with a focus on the evaluation of various analytical approaches used for ordinal outcomes in randomised controlled trials (RCTs).

Kristy Robledo

Kristy is a Senior Research Fellow in Biostatistics at the NHMRC Clinical Trials Centre at the University of Sydney. With experience working as a professional biostatistician in clinical trials for many years, she is now establishing herself as an academic researcher, supported by a NHMRC Emerging Leadership Fellowship.

Her methodological expertise focuses on prognostic models and the analysis of biomarker data, methods applicable across a wide range of disease areas. She is also passionate about reproducible research and enhancing researcher workflows, demonstrated in her leadership role as co-chair of R-Ladies+ Sydney.

Ian Marschner

Ian Marschner is Professor of Biostatistics at the University of Sydney and Director of Biostatistics at the NHMRC Clinical Trials Centre in Sydney, Australia. He has over 30 years of experience as a biostatistician working on clinical trials research across many therapeutic areas, with a recent focus on innovative clinical trial design.

He has published extensively on new statistical methodology for biostatistical applications and is a Chief Investigator for the Australian Trials Methodology Research Network. Formerly, he was Head of the Department of Statistics at Macquarie University, Director of Biometrics at Pfizer and Associate Professor of Biostatistics at Harvard University.

Elizabeth (Liz) Ryan

Dr Elizabeth (Liz) Ryan is a Senior Research Fellow in the Biostatistics Unit in the School of Public Health and Preventive Medicine, Monash University. Her PhD was on Bayesian statistical methods for the design of experiments, with applications in clinical trial design.

She has over ten years’ experience working as a clinical trials statistician in both Australia and the UK, across various health domains. Her current research interests include innovative clinical trial designs, particularly Bayesian adaptive designs and platform trials. She currently chairs the Australian Trials Methodology Research Network Adaptive Designs and Platform Trials Special Interest Groups.

Katherine (Kate) Lee

Prof Katherine Lee has over 20 years' experience in the design, planning and analysis of randomised trials. She is co-Director of the Clinical Epidemiology and Biostatistics Unit at the Murdoch Children's Research Institute and the University of Melbourne Department of Paediatrics, and the Associate Director: Biostatistics of the Melbourne Children's Trials Centre. She is the Deputy Chair of the Australian Clinical Trials Alliance Board of Directors, and is founder and co-Chair of their Statistics in Trials Interest Group. Katherine is also the Vice-President of the International Society for Clinical Biostatistics and a member of the Executive Committee for the Victorian Centre for Biostatistics (ViCBiostat) and the Australian Trials Methodology (AusTriM) reseach network. Her biostatistical research interests are in the method of multiple imputation for dealing with missing data and adaptive platform trials.

Steve Webb

Steve Webb is an Intensive Care specialist and a Professor of Critical Care Research at Monash University. He is a past-Chair of the Australian Clinical Trials Alliance, the ANZICS Clinical Trials Group and of the federal Government’s Clinical Trials Collaborative Forum. He has been an investigator on trials with an accumulated sample size of more than 80,000 patients, is a named investigator on more than $190 M of competitive research funding and has published more than 250 manuscripts that have been cited 75,000 times, including multiple manuscript in NEJM (11) and JAMA (15). He has experience with Bayesian adaptive platform trials and other innovative designs such as cluster cross-over trials. He was the global leader of the REMAP-CAP platform trial that reported the treatment effect of 18 different interventions for patients with severe COVID-19 infection.

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