Über 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)
Französisch
Muttersprachlich oder zweisprachig
Englisch
Verhandlungssicher
Vor Ort möglich
Barcelone (bis zu 50 km)
Projekt- und Berufserfahrung
- IndependantAdvisor - Real World Evidence & HEORPHARMAZEUTISCHE INDUSTRIEJanuar 2025 - Heute (1 Jahr und 5 Monate)Barcelona, SpainI 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
- Alira HealthDirector Real World EvidenceJanuar 2021 - Dezember 2024 (3 Jahre und 11 Monate)Barcelona, SpainKey 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
- IQVIAEngagement ManagerMärz 2018 - Dezember 2020 (2 Jahre und 9 Monate)Paris, FranceKey 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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Ausbildung und Abschlüsse
- M.Sc., Public Health, Methodology and statistics in biomedical research:Paris-Saclay University2002M.Sc., Public Health, Methodology and statistics in biomedical research:
- Bachelor of Science in Public HealthPaul Sabatier university2001B.Sc., Public health: