Curriculum Vitae
Personal Information
Name: Céline Fabre Professional Title: CEO / Head of Biostatistics Department Current Position: CEO / Head of Biostatistics Department Institution/Organization: Horiana (Health Data Consulting) Email: celine.fabre@horiana.com
Professional Qualifications
Scientific Degree(s)
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Degree: Master's Degree in Public Health (specialty: research in public health) Institution: University Paris V Year: 2013
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Degree: Licence in Statistics and Informatics for Health Institution: University Paris V Year: 2009
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Degree: University Diploma (DU) — Statistical Methods of Regression in Epidemiology Institution: University Bordeaux 2 Year: 2007
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Degree: University Diploma (DU) — HIV Infection and Viral Hepatitis Institution: University Bordeaux 2 Year: 2006
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Degree: DUT — Statistics and Data Management Institution: University Paris V Year: 2001
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Degree: DEUG — Mathematics Applied to Social Sciences Institution: University Paris X Year: 1998
Additional Qualifications and Certifications
- Statistical methodologies: Sample size calculation, randomisation lists, descriptive statistics, analysis of variance, survival analysis, mixed models, GEE models, logistic regression, GLM regression, meta-analysis
- Teaching: Statistical classes at master's level (ISPED, Bordeaux; UPC, Paris)
- Languages and tools: English fluent (oral and written); SAS (Base, Macro, Graph, Stat), R, SPSS, ENNOV CLINICAL, MS-Pack Office, nQuery Advisor, ACCESS
MDR Annex XIV Compliance — Qualifications of Clinical Evaluators
As per MDR 2017/745 Annex XIV Section 1, the following qualifications are confirmed:
a) Appropriate scientific education:
- Scientific qualification: Master's Degree in Public Health (specialty: research in public health), University Paris V (2013); Licence in Statistics and Informatics for Health (2009); University Diplomas in regression epidemiology (2007).
- Field of specialisation: Biostatistics, public health, epidemiology.
b) Training and experience in clinical research methodology:
- Years of experience: 22 years in clinical trials and observational studies.
- Methodological expertise: Statistical design, analysis and reporting of Phase I–III clinical trials and observational studies; survival analysis; mixed and GEE models; meta-analysis; sample-size calculation; randomisation.
- Evidence-based medicine: Extensive experience appraising and analysing primary clinical data across multiple therapeutic areas; teaching of statistical methodology at postgraduate level.
c) Competence in the relevant medical field and knowledge of the device:
- Clinical-trial experience: 9 years at INSERM (infectious diseases, vaccine trials); 3 years in oncology (Pierre Fabre); further work in cardiology, orthopaedics, gynaecology (Capionis/CROs).
- Medical-device experience: The external methodological review engaged was specifically scoped to a Class IIb medical device software clinical evaluation, covering the MDCG 2020-1 three-pillar framework and MDCG 2020-6 evidence hierarchy.
- Understanding of intended use and clinical performance: The external review deliverables addressed pillar mapping, evidence ranking, indirect clinical-benefit demonstration and surrogate-endpoint anchoring.
d) Understanding of regulatory requirements:
- MDR 2017/745 Annex XIV: External review scope covered MEDDEV 2.7/1 Rev 4 clinical-evaluation methodology and reporting requirements.
- MDCG guidelines: MDCG 2020-1 (three-pillar framework), MDCG 2020-6 Appendix III (evidence hierarchy), Class IIb indirect-benefit surrogate-endpoint anchoring.
Professional Experience
Current Position
Position: CEO / Head of Biostatistics Department Institution: Horiana (Health Data Consulting), Bordeaux (France) Duration: Since September 2023
Previous Relevant Positions
Position: Head of Biostatistics Department Institution: Horiana (Health Data Consulting), Bordeaux (France) Duration: September 2021 – September 2023
Position: Senior Biostatistician Institution: eXYSTAT, Malakoff (France) Duration: March 2021 – September 2021
Position: Senior Biostatistician Institution: ITEC Services, Bordeaux (France) Duration: March 2020 – March 2021
Position: Senior Consultant in Biostatistics Institution: Capionis, Bordeaux (France) Duration: September 2017 – March 2020
Position: Biostatistician Institution: INSERM U1219, Bordeaux (France) Duration: September 2015 – September 2017
Position: Biostatistician Institution: CAFAT, Nouméa (New Caledonia) Duration: July 2013 – July 2014
Position: Biostatistician Institution: INSERM U897, Bordeaux (France) Duration: September 2005 – July 2012
Position: Biostatistician Institution: Pierre Fabre, Boulogne-Billancourt (France) Duration: September 2001 – August 2005 Key Responsibilities: Biostatistical support for Phase I–III oncology clinical trials.
Clinical Evaluation and Research Experience
Experience with Medical Devices
- Years of experience in medical device evaluation: External methodological review of a Class IIb Medical Device Software clinical evaluation (2026).
- Types of devices evaluated: AI-based medical device software for dermatological image analysis.
- Regulatory experience: MEDDEV 2.7/1 Rev 4; MDCG 2020-1; MDCG 2020-6.
Clinical Research Experience
- Phase I–III clinical trials: Extensive experience including vaccine trials (INSERM, Ebola PREVAC trial), oncology trials (Pierre Fabre, Capionis), infectious disease cohorts (ANRS studies, COHERE collaboration).
- Observational studies: Longitudinal cohorts, registry-based studies, real-world data analyses.
- Meta-analysis and systematic reviews: Applied across multiple therapeutic areas.
Expertise Relevant to This Evaluation
Technical Expertise
- Statistical methodology: Sample-size calculation, randomisation, survival analysis (Kaplan–Meier, Cox), mixed models, GEE, logistic regression, GLM, meta-analysis — all directly applicable to appraising the statistical validity of the clinical studies in scope.
- Clinical-evidence appraisal: 22 years of experience evaluating clinical data quality, study design appropriateness, and analytical validity in primary and observational research.
Regulatory Knowledge
- MEDDEV 2.7/1 Rev 4: Clinical-evaluation methodology and reporting framework — directly applied in the external review.
- MDCG 2020-1: Three-pillar framework for Medical Device Software clinical evidence (Valid Clinical Association, Technical/Analytical Performance, Clinical Performance).
- MDCG 2020-6 Appendix III: Hierarchical evidence ranking — applied to classify evidence submitted in support of the clinical evaluation.
Publications and Communications (Selected)
Oral Communications
- 2023 Congrès SFA Lyon — Méthodes innovantes pour pallier l'absence de randomisation dans les études cliniques.
- 2017 Congrès EPICLIN Saint-Etienne — Opérationnalisation de la randomisation d'un essai vaccinal en population générale africaine (PREVAC).
Selected Peer-Reviewed Publications
- Sonnery-Cottet B, Fabre C et al. Knee Lateral Extraarticular Tenodesis Procedures. Arthroscopy. 2024. doi:10.1016/j.arthro.2024.02.041
- Nasser M, Larrieu S, …, Fabre C et al. Progressive fibrosing interstitial lung disease: a clinical cohort (PROGRESS® study). Eur Respir J. 2020. doi:10.1183/13993003.02718-2020
- Jahnmatz M, Richert L, …, Colin C (Fabre) et al. Safety and immunogenicity of live attenuated intranasal pertussis vaccine BPZE1. Lancet Infect Dis. 2020;20(11):1290–1301.
- Hessamfar M, Colin C (Fabre) et al. Severe morbidity according to sex in the era of combined antiretroviral therapy (ANRS CO3). PLoS One. 2014.
- Mocroft A, …, Fabre-Colin C et al. The incidence of AIDS-defining illnesses at CD4 ≥ 200 cells/μL. Clin Infect Dis. 2013;57(7):1038–47.
- Yazdanpanah Y, Fagard C, …, Colin C (Fabre) et al. High rate of virologic suppression with raltegravir plus etravirine (ANRS 139 TRIO). CID. 2009;49(9):1441–9.
Languages
- French: Native
- English: Fluent (oral and written)
Declaration
I declare that the information provided in this curriculum vitae is accurate and complete to the best of my knowledge.
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