Provide expertise and advise in Pharma R&D on development plans, study designs, responses to health agencies, etc

Involved in due diligence, development plans, study designs, defence of strategies with Health Agencies (FDA, PMDA, EMA or others (CANADA)) and bringing projects to a successful conclusion. Member of the development committee.Provided major input into study designs, endpoint definitions, study assumptions and sample sizes, success criteria per study and overall, for early proof of concept up to phase 3 pivotal trials. Made best use of the most knowledgeable & exhaustive past data from publications and SBA’s. Successful in >90% of phases 3 by adequately powering the studies.Statistical advisor in development plans, study designs and protocols, report/CTD writing and review of drugs, devices, or combinations for multiple skin diseases.Approved statistical analysis plans and statistical SOPs, delivered topline results with clear interpretations in the context of previous knowledge, identifying informative post-hoc analyses.Provided statistical arguments and responses to top management and Regulatory Authorities; company representative in multiple meetings at FDA, PMDA and EU agencies. Was successful >95% of the time in convincing peers from agencies by providing appropriate answers regarding statistical issues.Co-authored publications and patents

Managed a team of statisticians and data managers, worldwide (EU, US, JP). Involved in multiple projects from early to late phases and for process improvements. Managed the growth of team, from 1 to 20 people; managed, motivated and harmonised the worldwide R&D Biometrics teams located in EU, US and JP. Encouraged and supervised the transition from paper CRF to eCRF, and from internal database standards to CDISC

Managed a small team of statisticians working in non-clinical and clinical areas (from early to late phases). Before hiring people in 1995, was the single responsible statistician.

Managed the Statistics-France Unit. Dotted line reporting to the Director of Scientific Evaluation dept in the USA (headquarters of the parent company GD Searle & Co., at the origin of the GLP’s, later acquired by Monsanto).

Support provided to all scientists from basic research up to clinical and marketing studies. Produced several specific computer programs (Fortran, basic) dedicated to users for randomisations, data management, modeling, statistical analyses and graphics.