Marseille, Provence-Alpes-Côte d'Azur, France
With >13 years of experience in industry, biotech, comprehensive cancer centers, and university institutes, my background is primarily in statistical methodologies including survival analysis, biomarkers, gene signatures, and high-dimensional data. I have worked in clinical development, translational medicine, and methodological research. My interest is focused on driving oncology drug development, by combining quantitative methods with wide view of clinical & translational research and development. My international experience spans across France, Belgium, and Italy. As a manager, I have overseen a total of 3 data managers, 5 statisticians, 3 PhD students, and 5 MSc trainees. My main achievements include setting up a Biometrics Unit from scratch, designing and conducting a pivotal trial, and providing statistical support for FDA Fast-Track Designation and EMA PRIME applications. I have implemented a biomarker-safety joint model for dose optimization and published 31 peer-reviewed papers, including 9 as a first author and 4 as a corresponding author.
Leading early-stage oncology projects, with both in-house studies and in collaboration with other pharma companies. Contributing to the design of new trials, the protocol set-up, the definition of the TPP, the long-term / late-phase strategy, the CDP, the go/no-go criteria, the planning of activities and resources to secure milestone achievement, the oversight of study-level statisticians.
In charge of biomarker statistical activities for four oncology trials. Implemented a joint modelling with biological activity and safety for dose selection in oncology phase-1 trials.
Independent biostatistics consultant in oncology clinical development.
Biomarker Statistician in Oncology on behalf of Sanofi
Statistical support to successful applications for FDA Fast-Track Designation (FTD) and EMA PRIME for lacutamab. Participation in MAA submission in Europe for moxetumomab pasudotox-tdfk
Set-up of a Biometrics Unit from scratch Design and conduct of a pivotal trial
Research on methods for: validation of surrogate endpoints, development and validation of genomic signatures, multi-state models, frailty models, copula models, simulation studies. Co-supervision of PhD students (3) and MSc students (3)