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Biométrie/ Biostats

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Statisticien
Catégorie :

Biométrie/ Biostats

Date de dernière mise à jour :

23 janvier 2012

Lieu :

Paris

CV :

SENIOR BIOSTATISTICIAN Fluent In English

CAREER HISTORY
Nov 2005 – Jul 2011
BIOMETRY DPT MANAGER / SENIOR BIOSTATISTICIAN


I was responsible for the management of 6 people (programmer & data manager) in the conduct of data collection & data management of several phase II to phase IV studies in various domains (Oncology, infectiology, CNS, gastro enterology).
I was also in charge of the statistical analyses of phase II to IV clinical studies in oncology.
I also had to manage other transversal projects around the set-up of an EDC that includes complete system validation, SOP development, system maintenance and FDA system audit.
I attend several investigator meetings around the world to perform presentation of the statistical and the data collection aspects of protocols.

MAIN TASKS:

Management of the biometry team in project execution :
o Budget evaluation
o Assessment of the appropriateness of the resources in regards to the type and the volume of work projected
o Work dispatch according to individual expertise
o Team guidance & supervision
o Work progress checking
o Budget tracking
o Quality monitoring

Operational activities in Statistics & Data Management
o Methodology expertise in statistics & data collection / management
o Writing of statistical section of the protocol
o Writing of analysis plans
o Statistical programming using SAS
o Results interpretation & statistical report writing
o Oral presentations & administration of internal and external training
o SOP writing in statistics
o e-CRF conception

Supervision of the set-up and maintenance of an EDC solution :
o System validation : operational & performance qualifications
o Development of tracking tools
o SOP writing & revision
o Development of randomization module
o Conception & follow-up of key performance indicators


Sep 1993 - Jul 2005
BIOMETRY DPT MANAGER / SENIOR BIOSTATISTICIAN


I was in charge of the statistical analyses of mainly phase III to IV studies but also epidemiological and pharmaco-economic studies. Study Domains were diabete, transplantation, CNS and CVS diseases.
I was involved from an early stage of study development and consulted regarding statistical methods and sample size calculation, until the writing of the medical report based on the statistical report that I produced.
I was also in charge of the management of the biometry department of Quintiles in Paris for several years and had to supervise up to 4 statisticians and programmers and 2 data managers.

MAIN TASKS
Management of statisticians & statistical programmers in project execution :
o Budget evaluation
o Work dispatch
o Work progress checking
o Budget tracking
o Quality monitoring

Statistics
o Methodology expertise in statistics
o Writing of statistical sections of the protocol
o Writing of analysis plans
o Statistical programming using SAS
o Results interpretation & statistical report writing
o SOP writing in statistics


Nov 1991 - Sep 1993
STATISTICIAN / DATA MANAGER


I was in charge of the data collection supervision, data management and statistical analysis of several phase III studies in various domains such as gastro-enterology, ophthalmology, diabete, FIV.

Data Management
o CRF conception
o Database cleaning

Statistics
o Statistical programming using SAS
o Statistical report writing.


EXPERIENCE IN STATISTICAL METHODOLOGY & DATA MANAGEMENT

Therapeutic Areas :
Oncology, C.N.S & C.V.S diseases, diabete, organ transplant, ophthalmology. infectiology

Clinical studies (phase II to IV)
o Calculation of number of subjects required,
o Parametric and nonparametric tests,
o Analysis of (co) variance,
o Repeated measures analysis,
o Multiple and logistic regression,
o Survival data,
o Principal component analysis, factor analysis.

Epidemiological & Pharmaco-economic studies
o Measure of disease frequency & relation between disease & exposure
o Multivariate analyses : logistic & cox models
o Cost minimization & cost-efficacy analyses,
o Bootstrap sampling.

Quality of life studies
o Score calculation,
o Consistency and validity checks.

Data Management
o Design of pages,
o Export / import tables,
o Queries,
o Online randomization implementation,
o Users management & training

QUALIFICATIONS / EDUCATION

1990
Msc in Statistics - Biostatistics
« Institut Supérieur de Statistique des Universités de Paris- I.S.U.P ».

1990
Diploma in applied statistics in medicine
« Centre d’études statistiques appliquées à la médecine »
Option : Clinical Research.

1989
Certificate of statistical studies
« Institut Supérieur de Statistique des Universités de Paris- I.S.U.P ».

1986
DEUG « A »


TRAINING

2010
Computerized system validation
« Université René Descartes » (Paris).

2009
Cross-functional management
DOCENDI (Paris).

1999
Financial management
Quintiles (Levallois-Perret, France).

1997
Project management tools & techniques
Davis & Dean (Reading, UK).


INFORMATICS Data Processing
SAS (experience >20 yrs)

Electronic Data Capture (e-CRF) & Clinical Trial Management System.
Capture system

Microsoft
Word, Excel, Power Point, Project

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