Curriculum Vitae
Personal Information
Name: Antoine Giraud Professional Title: Biostatistician Current Position: Biostatistician Institution/Organization: Horiana (Health Data Consulting) Email: antoine.giraud@horiana.com
Professional Qualifications
Scientific Degree(s)
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Degree: Master's Degree in Public Health (specialty: Biostatistics) Institution: ISPED – University of Bordeaux Year: 2010
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Degree: Bachelor's Degree in Statistics, Computer Science Applied to Insurance and Health Institution: Niort Year: 2008
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Degree: University Degree of Statistics and Computing Institution: Niort Year: 2007
Additional Qualifications and Certifications
- Statistical methodologies: Study design, Statistical Analyses Plan (SAP), sample-size calculation, randomisation lists, descriptive and inferential analyses, study reporting; survival analysis (Kaplan–Meier, Cox, Fine-Gray); logistic and GLM regression; propensity scores; hypothesis testing; non-parametric tests.
- Standards: CDISC SDTM and ADaM.
- Languages and tools: Professional working proficiency in English; SAS (Base, Macro, Graph, Stat), STATA, R, MS-Pack Office.
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: Biostatistics), ISPED – University of Bordeaux (2010).
- Field of specialisation: Biostatistics, public health, clinical research methodology.
b) Training and experience in clinical research methodology:
- Years of experience: 15 years in clinical trials and observational studies.
- Methodological expertise: Statistical design and analysis of Phase I–III clinical trials and observational studies; SAP development; sample-size calculation; randomisation; CDISC ADaM/SDTM compliance.
- Clinical-trial experience: 10 years at Bergonie Institute (a specialist oncology and sarcoma centre), covering clinical trials and national-database observational studies.
c) Competence in the relevant medical field and knowledge of the device:
- Therapeutic-area experience: Oncology (sarcoma specialisation), gastroenterology, medical device, infectious disease, psychosocial fields.
- Medical-device experience: Clinical-trial statistical analysis in the medical device domain (Bergonie Institute); 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 evidence base for the intended use.
d) Understanding of regulatory requirements:
- CDISC standards: SDTM and ADaM; applied across clinical trial submission workflows.
- 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: Biostatistician Institution: Horiana (Health Data Consulting), Bordeaux (France) Duration: Since November 2022
Previous Relevant Positions
Position: Biostatistician / Data Manager Institution: Bergonie Institute, Bordeaux (France) Duration: February 2013 – October 2022 Key Responsibilities: Statistical analyses for Phase I–III clinical trials and observational studies, primarily in oncology (sarcoma) and other therapeutic areas including gastroenterology and medical devices.
Position: Database Manager Institution: Perinatal Network "Naître et Grandir", Montpellier (France) Duration: March 2012 – July 2012
Position: Statistical Studies Officer Institution: Inter Mutuelles Assistance, Niort (France) Duration: January 2011 – January 2012 Key Responsibilities: Economic analysis and statistical pricing studies.
Clinical Evaluation and Research Experience
Experience with Medical Devices
- Years of experience: Statistical analysis of medical device clinical trials at Bergonie Institute; external methodological review of a Class IIb MDSW clinical evaluation (2026).
- Regulatory experience: MEDDEV 2.7/1 Rev 4; MDCG 2020-1; MDCG 2020-6; CDISC standards.
Clinical Research Experience
- Phase I–III clinical trials: Extensive experience at Bergonie Institute, covering study design, SAP development, randomisation and statistical reporting.
- Observational studies: Cohort, case-control and national-database analyses.
- Role: Biostatistician (primary analysis, SAP, reporting).
Expertise Relevant to This Evaluation
Technical Expertise
- Statistical methodology for clinical evidence: Study design, sample-size calculation, SAP development, descriptive/inferential analysis — applied to assessing whether the gathered clinical evidence is sufficient for the intended use.
- Evidence adequacy assessment: 15 years of experience evaluating the statistical validity of primary clinical data and identifying methodological limitations.
Regulatory Knowledge
- MEDDEV 2.7/1 Rev 4: Clinical-evaluation methodology.
- MDCG 2020-1: Three-pillar framework for Medical Device Software clinical evidence.
- MDCG 2020-6 Appendix III: Hierarchical evidence ranking.
- CDISC SDTM and ADaM: Clinical data standards for regulatory submissions.
Publications and Communications (Selected)
Oral Communications
- 2025 SFA Nantes — La p-value sur la table d'opération: décryptage statistique d'un instrument interprété avec excès de confiance.
Peer-Reviewed Publications
Full publication list available at: https://scholar.google.com/citations?user=Jgp4dfwAAAAJ&hl=fr
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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