Experience

Cytel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Principal Statistical Programmer

  • Sep 2021 - Present

  Jansen Pharmaceutical (JnJ) in IDV departement - FSPo Leading project (individual study and Safety Pooling) & team members o Programming and validating CDISC datasets (ADaM model)o Programmation and Validatation of TLFso Creation of specification.o Use client Macros efficiently while programming TLFs and Datasetso Use of R to create graphs

• Senior Statistical Programmer

  • Sep 2019 - Sep 2021

  Jansen Pharmaceutical (JnJ) in IDV departement - FSPo Programming and validating CDISC datasets (ADaM model)o Programmation and Validatation of TLFso Create specification if needed.o Use client Macros efficiently while programming TLFs and Datasetso Use of R to create graphs



AIXIAL GROUP

• France
• Research Services
• 400 - 500 Employee

• SAS Analyste programmeur

  • May 2016 - Aug 2019

  • Mapping of data into CDISC standards : SDTM • Writing and Validation of ADAM Specifications according to the controlled terminology • Programming of compliant datasets SDTM / ADaM • Validation with PINNACLE 21 (OpenCDISC) • Writing of Study Data Reviewer Guide (SDRG) and Analysis Data Reviewer guide (ADRG) • Optimisation / standardisation of programs • Supports on setting up of documentation for blind review • Derivation of Patient Profile • Mapping of data into CDISC standards : SDTM • Writing and Validation of ADAM Specifications according to the controlled terminology • Programming of compliant datasets SDTM / ADaM • Validation with PINNACLE 21 (OpenCDISC) • Writing of Study Data Reviewer Guide (SDRG) and Analysis Data Reviewer guide (ADRG) • Optimisation / standardisation of programs • Supports on setting up of documentation for blind review • Derivation of Patient Profile



Experis France

• France
• Information Technology & Services
• 700 & Above Employee

• SAS Analyste Programmeur (économie de la santé)

  • Jan 2015 - Apr 2016

  HEOR Methods Analytics, SANOFI AVENTIS • Programming statistical analyzes (economic model and reimbursement files) post-hoc clinical studies • Participation in project meetings (English) to be in line with the analysis needs

• SAS Analyste Programmeur

  • Jun 2014 - Dec 2014

  Biostatistics and Programming, SANOFI AVENTIS • Preparation for the submission package • Ensure the quality of deliverables documentation: specification validation (define file)• Validation of datasets analysis and reporting of phase III studies and pooled data (in-text tables, listings, statistical appendices)• Provision and validation of datasets in the format required for submission



Experis France

• France
• Information Technology & Services
• 700 & Above Employee

• Biostatisticienne

  • Oct 2013 - Feb 2014

  • Creation / validation of ADaM Derived Datasets (double programming) • Supports on setting up of documentation for Data Review Meeting • Validation of internalized or outsourced statistical analyzes (tables and listings) double programming • Creation / validation of ADaM Derived Datasets (double programming) • Supports on setting up of documentation for Data Review Meeting • Validation of internalized or outsourced statistical analyzes (tables and listings) double programming



Gecem (CRO)

• Biostatisticienne

  • Apr 2009 - Aug 2013

  • Redaction of Statistical analysis plan (phase II to IV, observational studies) • Check data consistency with the data management manager • Derivations of databases • Programming of statistical analysis • Participation and animation of Blind Review • Data Management • Redaction of Statistical analysis plan (phase II to IV, observational studies) • Check data consistency with the data management manager • Derivations of databases • Programming of statistical analysis • Participation and animation of Blind Review • Data Management



INSERM

• France
• Research Services
• 700 & Above Employee

• Biostatisticienne

  • Feb 2008 - Dec 2008

  • Check data consistency • Statistical analysis (parametric and non-parametric tests, Anova, regression model,...) • Presentation of the results • Participation in the development of abstracts and articles • Check data consistency • Statistical analysis (parametric and non-parametric tests, Anova, regression model,...) • Presentation of the results • Participation in the development of abstracts and articles