Pierre DIETHER

En résumé

Entreprises

• Cytel - Senior statistical programmer

  2016 - maintenant * Leads the programming activities for a trial, early phase project, indication, or publication activities
  * develops and support statistical programming computer system that are used in the production of statistical analysis plan (SAP)-planned tables, data listings and graphs integrated summaries of safety and efficacy, ad-hoc analyses and electronic submission deliverables, such as datasets, data documentation, programs, programming tables of contents, and patient profiles.
  * Responsible for monitoring and meeting assigned program.
  * Creating systems that assist the biostatistical programming staff and biostatistical staff to create tables, data listings, graphs and analysis for final reports, abstracts, posters, manuscripts, and other clinical publications.
  * Developing systems to support electronic regulatory submission
  * Providing systems and support system for clinical data management staff, clinical programmers, quality control staff, and biostatisticians
  * Producing and supporting systems that extract data from the clinical data base and building analyses databases composed of SAS datasets
  * Follow established standardized design and programming procedures
  * Provide mentoring to junior level SAS programmers
  * Assist in establishing standardized programming procedures and work instructions
  * Develop, enhance, evaluate and validate standardized macros and utility programs
  * Ensure that the regulatory requirements are met through validation/compliance activities
  * Develop and maintain clinical processing work flow systems.

• CRO : Clin Data Management - Analyste programmeur SAS / Data manager

  2007 - 2016 ( more than 8 years )
  
  * Society CLIN DATA MANAGEMENT (CRO Contract Research organization)
  Context Growth sector of the society Clin Data Management. (Sector of Biometry)
  
  Missions * Editing listings of individual data using SAS according to the specifications provided by the client. (more than 160 different studies)
  
  * Introduction to Data Management and verifying the coherence of a database, data warehouse, coding application. (Phase I to IV, up to 26,000 patients included)
  
  * Use of CRF and eCRF (Development of scenarios to test the eCRF. Annotation CRF/eCRF)
  
  * Implementation of coherence controls on the coding of the terms of a database.
  
  * Implementation of automated coherence controls in SAS in order to simplify the sending of DCFs (queries).
  
  * Setting up monitoring trackings for the promoter to have a real-time view of the base.
  
  * Versioning programs to update coding terms (MedDra - WhoDD)
  
  * Management and update of SAS serveur 9.4 and his client program.
  
  SAS programmation
  Acquired skills
  * In-house training ;
  * Training in an accredited center :
  * SAS macro language, advanced level
  * SAS Programming : Advanced Techniques
  
  Introduction to Data Management and Good Clinical Practice
  
  Introduction to Coding (use of different dictionaries: MedDRA / WHODRUG)

• Vinosafe - Computer and Network Administrator

  2004 - 2006 * Society VINOSAFE (SUNDOFFEN, FR)
  
  Context Computer and Network Administrator
  
  Computer and Network Administrator
  
  - Network part :
  Network management -- maintaining the proper functioning of the computer consisting of 20 stations, 3 servers, an outsourced backup system and two network printers.
  
  - Software part:
  Internal training of office workers in office tools and the use of ERP (Enterprise Resource Planning). Based software with an Oracle database to manage the commercial, statistical, and production activities.
  Accounting officer of digital messaging.
  Management and maintenance of three websites selling online (order validation and verification of the return in the bank, setting up new articles through a GED, creating a new web page)
  Implementation of daily statistics via Excel using Oracle queries.
  
  - Production part:
  Establishment of classifications and ranges for the use of ERP
  
  - Commerciale part :
  Creation of monthly newsletters
  Responsible for IT purchases: Purchases of multiple computers and components.
  Direct contact with various service companies working with VINOSAFE
  Referencing websites (Adwords and Overture)
  Photo editing (Adobe Photoshop)
  
  
  Introduction to PL/SQL and SGBD (ORACLE, MySQL)
  Introduction to Web languages (AJAX, PHP, HTML, JAVASCRIPT)
  Introduction to Objective-C : Iphone/Ipad
  

Formations

• 2-Year Computer Science Technical Degree With A Focus On Application Development , Formation Alterna

  Mulhouse 2004 - 2006 2-year computer science technical degree with a focus on application development

Réseau

• Roseline FUCHS