Martine M Fiore

Martine Fiore, PhD Nationality: French Notice Period: available immediately Mobile:- Email:-Address: 56, Chamberlain Place, London E17 6AZ SUMMARY Accomplished Statistician with over 10 years’ experience in the pharmaceutical, CRO, and biotech sectors, now transitioning into Data Science. Adept at statistical analysis, data modelling, reporting, and interpretation across multidisciplinary clinical and scientific research teams. Proficient in SAS, R, and Python with recent applications in machine learning and data science projects. Proven track record in delivering high-quality outputs, stakeholder engagement, grant writing, and cross-functional collaboration. KEY SKILLS & COMPETENCIES Statistical Analysis & Modelling Clinical Trial Design & Reporting (SAP, TLFs, CSR) CDISC Standards (SDTM, ADaM) Programming: SAS 9.4 (4 yrs), R (3 yrs), Python (1 yr) Machine Learning (regression, classification models) Survival Analysis, ANOVA, Mixed Models Project Management & Stakeholder Communication Data Visualization & Reporting International & Interdisciplinary Collaboration Scientific Research & Publication record Knowledge areas Validation of metrics for Medical Devices applications; MRI liver imaging (Perspectum Diagnostics, Oxford, 2018) Ig quantitative bioassays; analysis of variation from various instruments and batches (The Binding Site, Birmingham, 2017) Blood glucose measurements on diabetic and non-diabetic populations. Analysis of bias drift and error grid (Abbott Diabetes Care, Oxford, 2015) Scientific research in Oncology; B-CLL bioassays development Enzyme kinetics modelling non-linear regression Main statistical and data science methodologies applied: Supervised Learning techniques (Machine Learning algorithms) Standard Linear Regression + outliers detection (ESD, Grubb’s test), Logistic regression, knowledge of k-Nearest Neighbors, Support Vector Machines, Random Forests Two-way ANOVA (with and without interaction), post-hoc tests, ANCOVA, Bivariate Analysis (Correlation, Bland-Altman, Passing-Bablok regression and weighted Deming regression); Survival Analysis Linear Mixed Models/Repeated Measures International research experience (USA, UK) Supervision experience: training and supporting technician staff Project management experience: Wrote grant applications (obtained funding) Designed experimental projects within clinical research unit. Designed scientific protocols based on experimental and theoretical knowledge EMPLOYMENT 05/2023- 01/2025 TERUMO AORTIC Position: Senior Statistician Main responsibilities Statistical analyses; creation of summary tables for reports from registries data (RWE data analysis). Application of statistical modelling (logistic regression and survival analysis). Validation of statistical programs (SAS) Study Design; sample size calculations using summaries of the scientific literature and statistical software (SAS). Liaising with Clinical Study Managers and Medical Writers for best approach Project Consultancy; advise clinical department on the use of statistical methods Reviewed documents; statistical analysis plan, protocol, CRF SAS programming; deliver TLFs (technical and clinical success of devices used in clinical studies). Use of main procedures(PROC): POWER, TABULATE, REPORT, SGPLOT, GLIMMIX Main achievements GCP training certificate (CITI) Commmunication of results for presentation of abstracts at conferences SAS training 02/2022- 03/2023 IQVIA Position: Senior Statistician(FSP) Main Responsibilities Client (Roche) communications; acting as Lead Statistician on various studies in Neuroscience (Neuromyelitis Phase IIIb; Multiple Sclerosis Phase Ib) and Oncology (CNS Tumors Phase I/II) Review of deliverables outputs (tables, listings and figures) Interpretation of results and review of abstracts for presentation at international conferences QC of essential documents: CSR, IB, RMP Statistical Technical document writing (SAP) SAS programming: QC tables with inferential statistics (survival analysis) 09/2021-02/2022 PREMIER RESEARCH Position: Senior Statistician (Level II) Main Responsibilities Production and QC of deliverables (SAS programming) according to timelines Dataset programming Write sections of Statistical Analysis Plan Application of Statistical Methodology (Tables) and communication of results Draft internal reports Communication with Clinical Sponsor on studies Budget submissions 02/2021-09/2021 CYTEL Statistical Services & Software London Position: Senior Biostatistician, FSP (Level II) Main Responsibilities HTA evaluations: TLFs review; Analysis & Reporting Quality Control and reviewing tables; subject-level, time-to-event analysis CDISC (SDTM, ADaM) SAS programming (for QCing tables and statistical analyses) Collaborate with statistical programmers to ensure high quality deliverables for HTA submissions Contribute to the preparation of the written reports to effectively communicate results of HTA evaluations 02/2020- 01/2021 PHASTAR Chiswick, London Position: Senior Statistician-I Main Responsibilities Production and Quality Control of Tables, Listings and Figures CDISC Validation of (efficacy) datasets Statistical input to analyses (PROC GLIMMIX NLMIXED); programming and reporting (PROC REPORT). Assist in statistical analysis Oncology project: to reproduce results of and improve efficacy analyses of a survival model Sample size calculation projects Achievements Keeping with SOPs and ICH Guidelines Successful programming of listings, tables and figures for clinical trial Validated the use of GLMMs in statistical analysis 11/2018 to 01/2020Oxford University Nuffield Department of Population Health Position: Medical Statistician Main Responsibilities Provide statistical analysis to assist the trial coordinators in the running of the EMPA-KIDNEY and ORION-4 trials, Assist with the preparation of analyses for the Principal Investigators and Trial Steering Committees. Main Achievements Demonstrated understanding of a range of statistical concepts and techniques Prepared tables and figures for publication, programming in SAS and R SAS knowledge development; attended two SAS courses: Data Manipulation Techniques SAS Macro Essentials 1 12/2017 to 10/2018Perspectum Diagnostics Biotech R&D Position: Statistician/Data Scientist Main Responsibilities Generate graphs for testing various imaging metrics (R programming) Address Business Development requests; provided support to the regulatory submissions including updates to overview documents from template document, adding relevant tables. Use state-of-the-art statistical methods to improve existing methodologies (e.g generalised Additive Models and Robust inference). Identified opportunities for the application of modelling to data analysis Write articles (statistical section) to submit for publication in peer-reviewed journals Explore new avenues in statistics using internal data and for discovery analysis Provide statistical assistance to data analysts colleagues Participate in journal club Present findings at internal meetings R various packages (e.g. GAMlss framework) Main achievements Provided statistical evidence to validate metric use in imaging technology Publication of one article 12/2016 to 27/10/2017 The Binding Site, Biotech, UK Production Control Position: Statistician/Data Scientist Main Responsibilities Responsible for analysis of statistical data Address customers queries Collate datasets Draft analysis plans and reports Presentation of statistical methods to staff Main statistical methodologies: ANOVA, linear regression, Method Agreement Oncology (preclinical) Software used: R, SPSS, Minitab, Excel Main achievement Successfully implemented ANOVA techniques for the Production Department Validated the use of Excel Analyse-It for all staff 08/2015 to 03/2016Abbott Diabetes Care, Pharma, UK R&D Position: Statistician/Analyst Main Responsibilities Data cleaning and management; creating datasets from crf data Statistical summaries and plots for validation and efficacy reporting Validation of results from internal clinical trials Programming for the creation of tables, listings and figures according to statistical analysis plan Main statistical methodologies: Ordinary Least-Squares and Passing-Bablok Regression Diabetes (Phase III) Software used: SAS Main achievement Produced bias and error grid plots for performance readings of medical devices Validated results from the team Completed internal clinical report (non-diabetic study) EDUCATION Medical Statistics (MSc) University College London, UK,- Grade: Pass Statistics Graduate Certificate (BSc) Birkbeck College, London, UK,- Grade: Distinction Biochemistry (PhD) Universite Paris VII, France-USA,- Thesis: Analysis of the Cofactor Functions of Blood Coagulation Tissue Factor; Soluble Tissue Factor as a Model Grade: Cum Laude COURSES/PROFESSIONAL TRAININGS Internship in Data Analytics (Uptrail, May 2025)- Core skills development and Advanced Techniques Courses in Python and SQL (Udemy, since Feb 2025) Python for Data Science and Machine Learning Bootcamp- Python for DataVisualisation(matplotlib, seaborn), Introduction to Machine Learning algorithms with scikit-learn Learn Python Programming- Beginner to Master- (functions, loops, string methods, object-oriented programming) SQL-MySQL for Data Analytics and Business Intelligence- SQL best practices, Combining SQL and Tableau (in progress) “Post-Graduate Certificate in Education” –Goldsmith College – London, UK -) CONFERENCES/SEMINARS International Society of Thrombosis and Hemostasis (ISTH) – San Francisco, USA – 12/2008 International Society of Thrombosis and Hemostasis (ISTH)- Birmingham, UK- 12/2003 International Society of Thrombosis and Hemostasis (ISTH)-Denver, USA-12/1993 American Heart Association (AHA)-Houston, USA-11/1992 Gordon Research Conference on Hemostasis and Thrombosis-Vermont, USA-12/1992 COMPUTER SKILLS Microsoft Office Statistical packages: SAS, R, PYTHON LANGUAGE SKILLS French (native) English (fluent) German (basic) MEMBERSHIP IN PROFESSIONAL ASSOCIATIONS American Heart Association -) HOBBIES/INTEREST History Theme walks PUBLICATIONS Harrison SA, Dennis A, Fiore MM, Kelly MD, Kelly CJ, Paredes AH, Whitehead JM, Neubauer S, Traber PG, Banerjee R. PloSOne 13 (9), 2018. “Utility and variability of three non-invasive liver fibrosis imaging modalities to evaluate efficacy of GR-MD-02 in subjects with NASH and bridging fibrosis during a phase-2 randomized clinical trial”. Rezaie AR, FioreMM, Neuenschwander PF, Esmon CT, and Morrissey JH. Prot Exp Purif 3: 453-460, 1992. “Expression and purification of a soluble tissue factor fusion protein with an epitope for an unusual calcium-dependent antibody”. Fiore MM, Neuenschwander PF, and Morrissey JH. Blood 80:-, 1992. “An unusual antibody that blocks tissue factor/factor VIIa function by inhibiting cleavage only of macromolecular substrates.” Neuenschwander PF, Fiore MM, and Morrissey JH. J Biol Chem 268:-, 1993. “Factor VII autoactivation proceeds via interaction of distinct protease-cofactor and zymogen-cofactor complexes: implications of a two-dimensional enzyme kinetic mechanism”. Fiore MM, Neuenschwander PF, and Morrissey JH. J Biol Chem 269:143-149, 1994.“The biochemical basis for the apparent defect of soluble mutant tissue factor in enhancing the proteolytic activities of factor VIIa.”. Clasper S, Vekemans S, Fiore M, Plebanski M, Wordsworth P, David G, and Jackson DG. J Biol Chem 274:-, 1999. “Inducible expression of cell surface heparan sulphate proteoglycan syndecan-2 (Fibroglycan) on human activated macrophages can regulate fibroblast growth factor action”. Fiore MM. Biochem Biophys Res Comm. 284:384-388, 2001.”Cellular specificity for the activation of fibroblast growth factor-2 by heparan sulphate proteoglycan” Fiore MM, and Kakkar VV. Biochem Biophys Res Comm 311:71-76, 2003. “Platelet Factor 4 neutralizes heparan sulphate-catalyzed antithrombin inactivation of factor Xa by preventing interaction of enzyme with polysaccharide”. Fiore MM, and Mackie IJ. Biochem Biophys Res Comm 379:-, 2009 Dual effect of Platelet Factor 4 on the activities of Factor Xa Fiore MM and Mackie IJ. Thromb Res, 2009. Low-Molecular-Weight Heparin Reversal by Platelet Factor 4 References Mackie I, Reader in Haemostasis, Department of Haematology, Haemostasis Research Unit, 51, Chenies Mews, London WC1E 6HX. Tel:-. Email:-Mushtaq A, Head of Production Control, The Binding Site 8, Calthorpe Road, Birmingham B15 1QT. Tel:- Dennis, A., Innovation Department Manager, Perspectum Diagnostics, Oxford. Tel:-. Email:-Kelly, M. , Innovation Department Head, Perspectum Diagnostics, Oxford. Tel:-. Email:-Jones, S., Director of Biostatistics, IQVIA. Tel:-. Email:-Merkle, V., Senior Director of Scientific Affairs, Terumo Aortic, Sunrise, Florida, USA. Tel: -. Email:-