During my 20 years working as a biostatistician, I collaborated with pharmaceutical and biotech companies, as well as CROs, in Europe, the US and Asia.
I have been helping companies with the preparation of regulatory submissions (ISE/ISS), including interactions with the FDA, MHRA and EMA. My core experience is in vaccines, ophthalmology and rare diseases.
In recent years, I have mainly collaborated with start-ups and small groups, which I particularly enjoy. I’ve been supporting them in the design of their clinical trials and in the management of their providers for the generation of tables and listings, with guidance on CDISC formats. I also served as an unblinded statistician for DMCs/DSMBs.
I have worked and lived in many countries throughout the World during my career. I am fluent in English, while French is my mother tongue.