Freelancer profile translated to English.

Description

Hello and welcome to my Malt profile 👋

Freelance consultant in methodology and biostatistics in the field of clinical research and health**, I intervene for **support missions**, especially with manufacturers of **medical devices

🟢 Do you want to set up aclinical investigation plan to evaluate a medical device (**feasibility study**,pivotal study,**SCAC / PMCF** )?

Here are themissions🎯 that I regularly carry out:

✔️Auditof themethodologyandbiostatisticsof clinical investigation protocols

✔️Study design

✔️Development and validation of associated objectives and criteria

✔️Sample size calculation

✔️ **Writing of methodology elements**,

✔️Writing of the**statistical analysis plan**

🟢 Do you want to carry out thestatistical analysis of acquired data?

Here are my skills

✔️Descriptivestatistical analyses

✔️Univariatestatistical analyses,multivariatestatistical analyses.

✔️ Evaluation ofeffectiveness(superiority and equivalence tests)

✔️ Research ofrisk factors: linear regressions, logistic regressions

✔️Survivalanalyses:Kaplan Meiercurves, log rank test,Coxmodel

✔️Diagnosticstudies: specificity, sensitivity, ROC curves

✔️Concordancebetween two measures: Bland Altman, ICC

✔️Predictiveanalyses

✔️Validationand Analysis ofself-questionnaires

Don't hesitate to contact me!

Industry field of expertise

Languages

English
Fluent
Italian
Basic
French
Native or bilingual

Workplace preferences

Remote only

Primarily works remotely

EssilorLuxottica International - Women@EssilorLuxottica FR
On Malt
Methodological support for the submission of a clinical investigation protocol for a medical device
March 2024 - June 2024 (4 months)
We validated the objectives of the investigation, as well as the evaluation criteria, in collaboration with the Essilor Luxottica team

We then calculated the number of subjects required, then designed and wrote the statistical analysis plan, as well as all the methodology elements of the protocol.
Sample size Medical device Statistical data analysis Data analysis Medical device Clinical trials Methodology Statistical analyses Health writing Clinical research Clinical Methodology Statistical Data Analysis Health Medical devices Statistical processing Sample size calculation Statistics Biostatistics Clinical study Clinical studies Medical devices Methodology Sample size calculation Statistics
EssilorLuxottica
Clinical methodology consultant (screening MD in the field of vision - feasibility study)
MEDICAL
February 2024 - Today (2 years and 4 months)
Validation of the objective and the main criterion
Validation of secondary and exploratory objectives and criteria
Sample size calculation,

Writing of the statistical analysis plan
Methodology medical device Clinical research Health Health writing
Divers clients
Some examples of recent support and training missions
MEDICAL
January 2019 - April 2024 (5 years and 4 months)

✅Assistance for writing responses to evaluators on statistical aspects in funding requests (Cilcare - April 2024)

✅ Audit of a clinical investigation protocol for a medical device in the dental field (MediAxe - February 2024)

✅ Statistical analysis of survey data in the field of dermatology (Emma, February 2024)

✅ Statistical analyses for evaluating the effectiveness of mosquito traps (Faculty of Medicine - University of Strasbourg, December 2023)

✅ Training in programming in R language (CEA, November 2023)

✅ Refreshing in biostatistics with Jamovi (Cilcare, October 2022)

✅ Statistical analyses for evaluating the effectiveness of a mandibular advancement orthosis in the treatment of obstructive sleep apnea-hypopnea syndrome (MD101, January 2022)

✅ Support for the development of a module for calculating the number of subjects required for the EasyMedStats software (November 2021)

✅ Selection of statistical methods used in preclinical studies and programming of these in R language (Cilcare, May 2021)

✅ Calculation of the number of subjects required to evaluate the sensitivity of a new diagnostic device (NGBiotech)

✅ Analysis of the evolution of the quality of life score (SF12 questionnaire), after coaching sessions and research of predictive factors of improvement (Medical thesis)

✅ Evaluation of the concordance of two blood dosage methods by the Passing and Bablok regression method (Bio Predictive)

✅ Assistance with PMSI data analysis with R software (Datamis)

✅ Research of predictive factors of poor response to a gynecological treatment, and development of a predictive score

✅ Statistical analyses in the context of medical theses: questionnaire analyses, research of predictive factors, etc...

✅ Press review of medical articles in hematology

descriptive analyses data-visualization methods concordance predictive score Health Public health Data analysis Statistical data analysis Writing design Quantitative studies Methodology investigations