Germain Lonnet

Led the statistical analyses, interpretations, and presentations of RWE

• • oncology studies results based on retrospective observational databases: EHRs and data registries (Immucan, COTA, ConcertAI). Supported the writing of the protocol by providing statistical expertise. Developed Statistical Analysis Plans (SAP): objectives, endpoints, design, population definitions, sample size calculations, statistical analyses, table shells. Performed statistical analyses using Posit (RStudio). Created an R package for RWE statistical analyses using Roxygen2. Wrote the statistical report and interpreted the study results.

Professional development

Led the statistical analyses, interpretation and presentation of RWE

vaccines studies results based on retrospective observational databases

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Supported the writing of the protocol by providing statistical expertise

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Developed Statistical Analysis Plans

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Programmed analysis using SAS and/or supervised programming teams

based in India, ensuring quality and timely delivery of study results

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Acted as the person of contact for studies related to a specific Vaccines

asset: definition of the study objectives, feasibility assessment, risk

assessment, resources allocation, timelines definition

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Presented a poster on Rheumatoid Arthritis at EULAR conference (2024)

Programmed and validated SDTM and ADaM datasets and programming

• • specifications for oncology studies (Phase II-III) for both efficacy and safety endpoints