Novartis Statistical Methodology Group

The Statistical Methodology group supports the development and implementation of innovative statistical methods that ensure efficient and tailored study designs and analysis approaches.

Expertise within the Group covers many areas, including multiplicity adjustment (efficient multiple testing strategies in confirmatory studies, confirmatory adaptive designs), the application of Bayesian methodology, missing data, dose-finding (adaptive dose-finding studies, model-based methods), nonlinear mixed effect models, experimental design, bioequivalence, simulation and computational techniques and advising on regulatory acceptability of novel statistical approaches.

Key Personnel:

Professor Dr Frank Bretz
Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported methodological advances in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is an Adjunct Professor at the Hannover Medical School and the Shanghai University of Finance and Economics.

Professor Dr Byron Jones
Co-supervisor: Innovative designs for combination of existing therapies
Byron Jones joined Novartis in 2011, after a career spent in academia and the pharmaceutical industry. He is currently a Senior Biometrical Fellow in the Statistical Methodology Group. He is an expert in the design and analysis of cross-over trials and is the joint author of a standard text on the topic. He is also the coauthor of a book on bioequivalence studies and has research interests in the design and analysis of trials to compare biosimilars. He was formally a full university professor and is currently an Adjunct Professor at four UK Universities: University College London, London School of Hygiene and Tropical Medicine, Queen Mary, University of London and Leicester University.

Dr  Björn  Bornkamp
Björn Bornkamp joined Novartis in 2010 from academia. At Novartis he is working as a Statistical Methodologist in the Statistical Methodology Group. His statistical expertise focusses on Bayesian statistics, statistical methods for dose-finding and statistical computing.

IDEAS PhD Projects supervised and located at Novartis:

• Project 6: Optimal designs and analysis methods for the development of Biosimilars
• Project 7: Predictive probability of success, as a criterion at clinical development milestones