Curriculum Vitae
Personal Information
Name: Fabienne Diaz Professional Title: Senior Consultant in Statistics Current Position: Senior Consultant in Statistics Institution/Organization: Horiana (Health Data Consulting) Email: fabienne.diaz@horiana.com
Professional Qualifications
Scientific Degree(s)
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Degree: Ph.D. in Public Health and Medical Information Sciences Institution: University Pierre et Marie Curie, Paris VI Year: 2006
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Degree: MSc in Informatics and Statistics Applied to Human Sciences Institution: University Paris VII Year: 2007
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Degree: Master's Degree in Epidemiology and Public Health Intervention Institution: University Bordeaux II Year: 2002
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Degree: Undergraduate Degree in Applied Mathematics and Social Sciences Institution: University Bordeaux 2 Year: 2006
Additional Qualifications and Certifications
- Statistical methodologies: Study design, Estimand, Statistical Analyses Plan (SAP), sample-size calculation, randomisation lists, descriptive and inferential analyses, study reporting; survival analysis; mixed and GEE models; logistic and GLM regression; propensity scores; meta-analysis; pharmacoepidemiology and real-world data analyses.
- Standards: CDISC ADaM.
- Teaching: Statistics at master's level (University of Bordeaux); European training programme in Pharmacovigilance and Pharmacoepidemiology (epidemiology, descriptive statistics, regression, propensity scores).
- Languages and tools: Professional working proficiency in English; SAS (Base, Macro, Graph, Stat), R, MS-Pack Office, PASS.
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: Ph.D. in Public Health and Medical Information Sciences, University Pierre et Marie Curie, Paris VI (2006); MSc in Informatics and Statistics Applied to Human Sciences, University Paris VII (2007); Master's in Epidemiology and Public Health Intervention, University Bordeaux II (2002).
- Field of specialisation: Biostatistics, pharmacoepidemiology, public health, clinical research methodology.
b) Training and experience in clinical research methodology:
- Years of experience: Over 20 years in primary and secondary database studies (clinical trials Phase I–IV, cohort, case-control, self-controlled case series).
- Methodological expertise: Statistical design, SAP development, Estimand framework, sample-size calculation, randomisation; pharmacoepidemiology and real-world evidence; meta-analysis; propensity scores; CDISC ADaM.
- Teaching: Statistical classes at University of Bordeaux master's level and European training programme in Pharmacovigilance and Pharmacoepidemiology.
c) Competence in the relevant medical field and knowledge of the device:
- Therapeutic-area experience: Ophthalmology, gynaecology, oncology, gastroenterology, medical device, psychosocial fields; pharmacoepidemiology (11 years at INSERM and University of Bordeaux); multiple CRO roles.
- Medical-device experience: Clinical-trial and real-world statistical support in the medical device domain; the external methodological review engaged was scoped to a Class IIb medical device software clinical evaluation.
- Understanding of intended use and clinical performance: The external review deliverables addressed statistical validity, study-design appropriateness, evidence ranking and adequacy of the clinical evidence base for the intended use.
d) Understanding of regulatory requirements:
- CDISC standards: ADaM; applied across clinical trial and real-world study workflows.
- Pharmacovigilance and pharmacoepidemiology: European training programme faculty; PASS/PAES study design expertise.
- MEDDEV/MDCG: External review scope covered MEDDEV 2.7/1 Rev 4, MDCG 2020-1 (three-pillar framework) and MDCG 2020-6 Appendix III (evidence hierarchy).
Professional Experience
Current Position
Position: Senior Consultant in Statistics Institution: Horiana (Health Data Consulting), Bordeaux (France) Duration: Since February 2022
Previous Relevant Positions
Position: Senior Biostatistician Institution: eXYSTAT, Malakoff (France) Duration: May 2020 – February 2022
Position: Senior Statistician / Associate Statistics Director Institution: IQVIA France, Bordeaux (France) Duration: December 2019 – May 2020
Position: Senior Consultant in Biostatistics Institution: Capionis, Bordeaux (France) Duration: November 2018 – December 2019
Position: Senior Statistician / Statistics Department Manager Institution: ITEC Services, Bordeaux (France) Duration: December 2015 – November 2018
Position: Statistician Institution: DRUGS-SAFE Platform, Bordeaux (France) Duration: May 2015 – December 2015
Position: Statistics Department Manager Institution: Quanta Medical, Ruel Malmaison (France) Duration: November 2013 – December 2015
Position: Statistician Institution: Department of Pharmacology, University of Bordeaux, Bordeaux (France) Duration: September 2006 – November 2013 Key Responsibilities: Pharmacoepidemiology and real-world data analyses; statistical support for observational studies and drug-safety research.
Position: Ph.D. Researcher Institution: INSERM U444/U707, Paris (France) Duration: September 2002 – September 2006
Clinical Evaluation and Research Experience
Experience with Medical Devices
- Years of experience: Statistical support for clinical trials and real-world studies in the medical device domain; external methodological review of a Class IIb MDSW clinical evaluation (2026).
- Types of devices evaluated: AI-based and Class IIb medical device software; ophthalmic devices.
- Regulatory experience: MEDDEV 2.7/1 Rev 4; MDCG 2020-1; MDCG 2020-6; CDISC ADaM; pharmacovigilance regulatory frameworks.
Clinical Research Experience
- Phase I–IV clinical trials: Over 20 years of statistical support across multiple CROs and public research institutes, spanning oncology, ophthalmology, gynaecology, gastroenterology and pharmacoepidemiology.
- Observational and real-world studies: Cohort, case-control, self-controlled case series; French national database (SNDS/PMSI) analyses.
- Role: Senior statistician (statistical design, SAP, analysis, reporting, submission support).
Expertise Relevant to This Evaluation
Technical Expertise
- Statistical methodology for clinical evidence: Study design, Estimand, sample-size calculation, SAP development, propensity scores, meta-analysis — applied to assessing whether the gathered clinical evidence is sufficient for the intended use.
- Evidence adequacy and limitation identification: Over 20 years of experience evaluating the statistical validity and methodological robustness of primary and secondary clinical data, detecting evidence limitations and assessing whether the evidence base is adequate for the claimed indication.
Regulatory Knowledge
- MEDDEV 2.7/1 Rev 4: Clinical-evaluation methodology and reporting requirements.
- MDCG 2020-1: Three-pillar framework for Medical Device Software clinical evidence.
- MDCG 2020-6 Appendix III: Hierarchical evidence ranking.
- CDISC ADaM: Clinical data standards.
- Pharmacoepidemiology regulatory standards: PASS/PAES study design; European training programme faculty.
Publications and Communications (Selected)
Selected Peer-Reviewed Publications
- Delaroche L, Besnard L, Bazin (Diaz) F et al. The sequential use of IVF disposable devices: cumulative toxicity assessment. Sci Rep. 2026;16(1):5491.
- Newman NJ, Yu-Wai-Man P, …, Bazin (Diaz) F et al. Randomized trial of bilateral gene therapy injection for m.11778G>A MTND4 Leber optic neuropathy (LHON REFLECT). Brain. 2022.
- Cottin V, Larrieu S, …, Bazin (Diaz) F et al. Epidemiology, mortality and healthcare resource utilisation associated with systemic sclerosis-associated ILD in France. Front Med. 2021.
- Nasser M, Larrieu S, …, Bazin (Diaz) F et al. Estimates of epidemiology, mortality and disease burden associated with progressive fibrosing ILD in France (PROGRESS). Respir Res. 2021;22(1):162.
- Dumortier J, Duvoux C, …, Bazin (Diaz) F et al. Conversion from immediate-release to once-daily prolonged-release tacrolimus in liver transplant recipients (COBALT study). Ann Transplant. 2019;24:506–516.
- De Billioti Degage S, …, Bazin (Diaz) F et al. Benzodiazepine use and risk of dementia: a prospective cohort study. BMJ. 2012;345:e6231.
- Pariente A, Fourrier-Réglat A, Bazin (Diaz) F et al. Effect of treatment gaps in elderly patients with dementia treated with cholinesterase inhibitors. Neurology. 2012;78(13):957–63.
Languages
- French: Native
- English: Professional working proficiency
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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