Gaëlle Saint-Hilary

Statistical expertise to support innovation and decision-making in healthcare

• • Methodological support: Innovative clinical trial designs, decision-making, advanced statis tical models, dose-finding, historical data borrowing, benefit-risk assessment, meta-analyses and evidence synthesis, patient and expert elicitation, portfolio risk-value profiles.

• • Independent expert: Advisory boards and Data Monitoring Committees, statistical support for regulatory applications, risk assessment for due-diligence.

• • Training courses and seminars

Statistical expert acting as cross-project consultant

• • Support quantitative decision-making at project and portfolio levels.

• • Boost the performance of pre-clinical and clinical developments.

• • Develop innovative statistical methodologies.

• • Provide training to statistical staff, and establish partnerships with universities.

• • Share statistical expertise through international working groups and industry consortia.

• • Contribute to Servier's external visibility (posters, publications, conferences). Main research topics:

• • Bayesian designs, historical data

• • Decision-making frameworks, probabilities of success

• • Portfolio decision-making

• • Benefit-risk assessment, patient and expert preference elicitation

• • Event predictions, surrogacy

Clinical projects in Oncology

• • Responsible for the global development plan (Europe, US, Asia, pediatric development, and companion diagnostic) of a drug in Acute Myeloid Leukemia (AML).

• • Phase II/III clinical studies, including a Phase III registration trial co-sponsored with a US cooperative group.

• • Statistical lead for US (FDA) and Europe (EMA) marketing authorization applications.

• • Independent statistician for a Data Monitoring Committee of a Phase II clinical study in Head and neck squamous cell carcinoma.

• • Management of project teams and outsourcing. Main research topics:

• • Complex Group Sequential Designs (multiple endpoints, multiple populations)

• • Estimands, treatment switching

• • Multiple testing procedures

• • Simulation models for time-to-event data and predictions

• • Statistics for non-statisticians internal training program