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Mathieu RoséMR

Mathieu Rosé

Supermalter

Advisor - Real World Evidence & HEOR

1 200 €/jour
2 projets
Barcelone, ES
15 ans et +

Délai de réponse moyen : 1h

À propos de Mathieu

I provide RWE and HEOR services to pharmaceutical, biotech, and med tech
companies, at both global and European affiliate levels.

Key Roles:
  • Team & Project Leadership
  • RWE/HEOR Strategy Development & Implementation
  • Subject Matter Expert in biostatistics and pharmacoepidemiology

Resume: Senior professional with deep expertise in Real-World Evidence, pharmacoepidemiology, and biostatistics. Extensive experience within the pharmaceutical industry (global and affiliate roles), consulting, and academia. Proven track record in advising, designing and delivering real-world evidence studies in Europe, compliant with European Medicines Agency and Health Technology Assessment requirements.

Ability to travel: Open to working from any European city with convenient connections to Barcelona

Languages: French – native; English – fluent; Spanish – basic

SKILLS :

Leadership & Strategy :
  • RWE Study & Program Leadership
  • People & Line Management
  • Cross-Functional & Matrix Collaboration
  • Evidence Generation Strategy
  • Market Access & Medical Affairs Interfaces
Expertise:
  • Real-World Evidence (RWE)
  • Biostatistics, Data Science
  • HEOR & Outcomes Research
  • Pharmacoepidemiology & Epidemiology
  • European Data Privacy, Regulatory Frameworks
Therapeutic areas: Oncology, Hematology, Respiratory, Immunology, Rare diseases

Submission process:
  • PRAC (EMA) for Post-Authorisation Safety Studies (PASS).
  • HAS (French HTA) for non-interventional post-inscription studies (HDH/CESREES, CNIL MR004/006, CNAM).
Data sources experience:
  • Europe: Chart reviews, HCPs and patients’ surveys, Pharmacies longitudinal prescription claims, France: Claims (SNDS, PMSI), diseases registries, chart reviews / Germany: Claims (SHI), EMR / UK: CPRD-HES; / Spain: SIDIAP.
  • US: Claims (MarketScan, PharMetrics)
  • Français

    Bilingue ou natif

  • Anglais

    Capacité professionnelle complète

Accepte de travailler sur site
Barcelone (jusqu’à 50 km)

Expériences

  • Independant
    Advisor - Real World Evidence & HEOR
    INDUSTRIE PHARMACEUTIQUE
    janvier 2025 - Aujourd'hui (1 an et 5 mois)
    Barcelona, Spain
    I provide strategic RWE and HEOR services to pharmaceutical, biotech, and med tech companies, at both global and European affiliate levels.

    Key Roles
    • Team & Project Leadership
    • Strategy Development & Implementation
    • Subject Matter Expert in RWE, HEOR, and Epidemiology









    RWE HEOR Team Leadership Evidence generation strategy Real World Evidence
  • Alira Health
    Director Real World Evidence
    janvier 2021 - décembre 2024 (3 ans et 11 mois)
    Barcelona, Spain
    Key Responsibilities:
    • Lead and manage a team of RWE consultants (5–10 professionals)
    • Advise clients as an RWE subject matter expert on study design, methodologies, and data source assessment
    • Ensure operational excellence across multiple projects
    • Plan, organize, and manage resources to ensure successful delivery of project objectives
    • Business development for European RWE consulting services
  • IQVIA
    Engagement Manager
    mars 2018 - décembre 2020 (2 ans et 9 mois)
    Paris, France
    Key Responsibilities:
    • Lead the development of RWE study deliverables, including study protocols, statistical analysis plans, statistical analysis validation documents, statistical reports, and final study reports
    • Manage European PASS projects based on secondary data sources (claims, EHRs, registries), designed and conducted in compliance with EMA (PRAC) requirements
    • Plan, organize, and manage resources to ensure the successful delivery of project objectives

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Formations

  • M.Sc., Public Health, Methodology and statistics in biomedical research:
    Paris-Saclay University
    2002
    M.Sc., Public Health, Methodology and statistics in biomedical research:
  • Bachelor of Science in Public Health
    Paul Sabatier university
    2001
    B.Sc., Public health:

Compétences

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