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Shaima Belhechmi

Shaima Belhechmi

Senior / Principal biomarker Biostatistician

Talents
ParisMembre depuis 25 avril 2026
Longitudinal modelsSurvival analysisHigh-dimensional methodsPenalized regressionMachine learningSAP developmentCSRHealth authority submissionsScientific communicationsRPythonSASBiomarker StatisticsClinical TrialsImmunologyAtopic Dermatitis
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Longitudinal modelsSurvival analysisHigh-dimensional methodsPenalized regressionMachine learning

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)

Compétences

Senior / Principal biomarker Biostatistician

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