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.
Patients Data are the Raw Material. Well-thought Collection, Analysis & Integration are the Core of our Business.
I have 20 years experience within the Industry. During the past 10 years, I have gained knowledge in ophthalmology, with insight in imaging assessments, as well as visual acuity reporting.
More recently, I have been involved in clinical trials for rare disease whilst my early years were focused on vaccines.