Experience

HORIBA Scientific

• Research Services
• 700 & Above Employee

• Clinical Study Manager

  • Sep 2019 - Present

  - Lead of multicentric studies for FDA acceptance.- Planning and implementing the clinical study's goals and objectives.- Proficient in protocol design and writing.- Work with IRB regulation to comply with FDA guidelines in relation to clinical research.- Assist with establishing the budget for clinical trials.- Participation in contracts signing with sites. - Collaborator and external personnel training. - Collaboration and communication with multidisciplinary teams.- Manage relationship with site and the Principal Investigator.- Preparation and writing documents, inform consent, eCRF, Data Management Plan, Statistical Management Plan, Clinical Plan and Clinical Study Site Management Plan.- Lead and oversee of data management application for FDA 510k study.- Monitoring and checking of clinical studies. Show less

• Biostatistician

  • Dec 2015 - Sep 2019

  - Organize, process, analyze and interpret the data from different tests (verification, validation, monitoring…) carried out on devices, reagents and control bloods. - Retrieve and manage data from different instruments.- Implement regulatory standard for performance validation of in vitro diagnostic (IVD).- R programing.- Development of statistical tools under R software. - Data analyze by statistical tests and according to IVD standard.- Using parametric (Deming) and non-parametric linear regression (Passing-Bablok).- Data Mining: ACP, ACM, AFD, k-means, SVM.- Interpret the results.- Writing report.- Successful preparation to traditional FDA 510(k) submission for medical device.- Analyse and report the problems.- Participation in statistical methodogies.- Statistical process control (capability).- Respect of international guidelines.- VBA programming. Show less



AXONAL-BIOSTATEM

• France
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Biostatistician (intern)

  • Mar 2014 - Aug 2014

  - Realization of randomized multicenter phase III clinical study on bladder cancer. - Participation in prospective multicenter study on DOTAREM® (contrast agent for MRI). Realizations: - Define statistics methodologies. - Writing of the statistical analysis plan. - Protocols development. - SAS programming . - Realize statistical analyse in respect of protocol and European guidelines. - Interpret the results. - Writing statistical report. - Participation in the realization of the clinical study report. Show less



INSERM

• France
• Research Services
• 700 & Above Employee

• Epidemiologist

  • Feb 2012 - Aug 2013

  - Realization of epidemiological studies on CVA and myocardial infarction ST+. - Realization of observational study on the care of 75 years old elderly in the emergency healthcare. - Network organization in INSERM sentinel network in Rhône-Alpes. - Define statistics methodologies. - Protocols development. - Data collection. - Analysis and interpretation of results. - Writing scientific reports. - Communication of result to the healthcare provider. - Collaboration with the RésuVal and RENAU emergency network. Show less



Observatoire Régional de la Santé de la Guyane

• Scientific manager in epidemiology

  • Mar 2010 - Aug 2011

  - Realization of cross-sectional study on the determination of the factors being able to explain the difference of obesity prevalence at the pupils according to the geographical area during the year 2009-2010 in French Guyana.- Participation to development of the vaccine cover protocol in French Guyana.- Involvement in the writing report of the study "Analyse and propositions to building one perinatal health policy in French Guyana ". - Participation in the process quality.- Data collection.- Define statistics methodologies.- Protocols development.- Analysis and interpretation of results.- Writing scientific reports.- Presentation of results.- Management of team. Show less

• Studies manager in epidemiology

  • Jan 2008 - Mar 2010

  - Realization of observational study on the care of 65 years old elderly in the healthcare center of French Guyana.- Realization of cross-sectional study on obesity prevalence at the pupils of the elementary school during the year 2009-2010 in French Guyana, “NutriEl”.- Make an assessment about the pesticides found in French Guyana. - Make an assessment about the accidents of the everyday life in French Guyana. - Evaluation of cancer screening practices..- Data collection.- Define statistics methodologies.- Protocols development.- Analysis and interpretation of results.- Writing scientific reports.- Presentation of results. Show less