Shaima Belhechmi
Senior / Principal biomarker Biostatistician
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À propos
Senior biomarker biostatistician with 9+ years of experience across academia and pharmaceutical clinical development, including 4+ years at Sanofi. Lead statistical contributor to Phase II/III clinical studies in immunology, with strong expertise in biomarker-driven analyses, longitudinal and survival models, and high-dimensional data. Experienced in regulatory submissions, clinical study reporting, and cross-functional collaboration to support clinical development and decision-making.
Expérience
Biomarker Biostatistician at Sanofi (2022-05 – Present)
Lead biomarker statistical support and strategic delivery across clinical studies
- Lead biomarker statistical support across 12+ Phase II/III clinical studies in atopic dermatitis
- Provide statistical leadership for biomarker analysis planning including Statistical Analysis Plans
- Contributed to biomarker evidence supporting key clinical and regulatory decision-making
- Drive end-to-end biomarker strategy and delivery across Clinical Study Reports, regulatory filings, and scientific dissemination
- Partner with cross-functional teams across clinical, translational medicine, programming, data management, and medical writing
- Contribute to cross-study biomarker discussions and serve as a key contact for atopic dermatitis biomarker topics
Postdoctoral Research at Gustave Roussy, INSERM (2021-08 – 2022-04)
Methodological research in adaptive designs and survival analysis
- Contributed to methodological research in adaptive designs and survival analysis
- Worked on methods addressing non-proportional hazards and historical control settings
PhD in Biostatistics at Gustave Roussy, INSERM (2017-10 – 2021-07)
Developed statistical methods for biomarker identification in high-dimensional clinical trial data
- Developed statistical methods for biomarker identification in high-dimensional clinical trial data
- Applied penalized regression and survival models to oncology clinical trial datasets
- Conducted simulation studies and real-data applications, leading to peer-reviewed publications and international conference presentations
Biostatistician Intern at Gustave Roussy, INSERM (2017-02 – 2017-07)
Worked on bivariate survival modeling and surrogate endpoint validation
- Worked on bivariate survival modeling and surrogate endpoint validation using individual patient data meta-analysis
- Conducted simulation studies and applied methods to Phase III oncology trial data
Formation
PhD in Biostatistics – Université Paris-Saclay (2017 – 2021)
Engineering Degree in Statistics and Data Analysis – ESSAI (2013 – 2017)
