Yves-Marie Le Drogoff Email & Phone Number

Allschwil

[Scientific & Quality Systems][Data Architecture & Analytics]

Région De Basel, Suisse

Working as FSP for Novartis Pharma AG[Global Drug Development - Global Development Operations][Innovations and Technical Implementations]

Région De Basel, Suisse

[Global Drug Development - Global Development Operations][Technology, Standards & Processes]*** Provide support to clinical teams via users Forums (1st and 2nd level support) on:- CDISC- ADaM- Novartis Metadata- Codelists- Study setups*** Tools- Maintenance of Pinnacle21 Community within the programming environment.- Ensure/improve the CDISC Compliance of the Novartis Metadata.- Develop/implement SAS macros for study use and submission… Show more [Global Drug Development - Global Development Operations][Technology, Standards & Processes]*** Provide support to clinical teams via users Forums (1st and 2nd level support) on:- CDISC- ADaM- Novartis Metadata- Codelists- Study setups*** Tools- Maintenance of Pinnacle21 Community within the programming environment.- Ensure/improve the CDISC Compliance of the Novartis Metadata.- Develop/implement SAS macros for study use and submission delivery.*** Collaborate with - ADaM Governance Board- Data Standard Governance Boardto support study implementation.*** Review/test tools prior to be released.*** Usage of HP Application Lifecycle Management system.*** Improve collaborations between DI/Standard and Clinical teams. Show less

Région De Basel, Suisse

[Oncology – Biometrics & Data Management][Standards group]*** Draft documentation of Oncology Standard Outputs (OSO).*** Reporting tool:- Extend the TFL templates library based on the OSO content.- Create a tracking document for TFL templates library.- Provide users support via a forum.*** Create/maintain:- Tools such as “Calling Programs Generator” and “Checks Standard Tool”.- Tiddly Wikis for Tools/Processes guidance and… Show more [Oncology – Biometrics & Data Management][Standards group]*** Draft documentation of Oncology Standard Outputs (OSO).*** Reporting tool:- Extend the TFL templates library based on the OSO content.- Create a tracking document for TFL templates library.- Provide users support via a forum.*** Create/maintain:- Tools such as “Calling Programs Generator” and “Checks Standard Tool”.- Tiddly Wikis for Tools/Processes guidance and documentation.*** Documentation:Design- User Requirements (URS).- Functional/Design Specification (FS/DS).- Unit tests (UT).- Operational and Performance Qualification (OQ/PQ).- Traceability Matrix.- Project change management.for tools, macros or processes.*** Collaborate with other departments for the Maintenance of the Novartis Metadata content.*** Deliver monthly reports to internal/external partners.*** Novartis Metadata Extraction process:- Analyze the existing process.- Revise and improve it (optimization, flexibility, code updates, creation/implementation of new SAS modules, ...).- Validate this revised version by following non-GxP and CSV process.- Execute a monthly extraction in order to be available on time for clinical teams.- Provide end-user support via Forums. Show less

Région De Basel, Suisse

[Oncology - Biometrics & Data Management]- Evolving in a study clinical team.- Creation of main/QC Tables, Listings and Figures for both Safety and Efficacy.- PK merge validation.

Région De Basel, Suisse

[Modeling & Simulation]- Build a placebo database across different projects and studies.- Apply exploratory analysis on the different created datasets using SAS and/or R.- Creation of a report for submission to the university.- Oral presentation in front of a jury from the university.

Bsc, Statistics And Computing, Second-Class Honours, Upper Division (2:1)

Courses: - Operational Research and Mathematical Programming - Advanced Databases & The Web - Time Series & Futher Inference - Individual.

Associate'S Degree, Statistics & Business Intelligence (Stid)