Stefan Hofmann

Angestellt, Director, Clinical Data Integration and Standards, CSL Behring Innovation GmbH

Marburg, Deutschland

Fähigkeiten und Kenntnisse

SAS Programming
SAS-Software
CDISC Standards
Clinical Data Interchange Standards Consortium
Clinical Research
Clinical Data Management
Statistical Analysis
SQL-Programmierung
Study Data Standardization Plan
Data Integration
SDTM
ADaM

Werdegang

Berufserfahrung von Stefan Hofmann

  • Bis heute 1 Jahr und 6 Monate, seit Jan. 2023

    Director, Clinical Data Integration and Standards

    CSL Behring Innovation GmbH

  • 2 Jahre, Jan. 2021 - Dez. 2022

    Associate Director, Clinical Data Integration and Standards

    CSL Behring GmbH, Marburg

  • 2 Jahre und 4 Monate, Sep. 2018 - Dez. 2020

    Senior Manager, Clinical Data Standards and Programming

    CSL Behring GmbH, Marburg

  • 4 Jahre und 2 Monate, Juli 2014 - Aug. 2018

    Manager, Clinical Data Standards and Programming

    CSL Behring Innovation GmbH

  • 2012 - 2014

    Validation Lead SAS Programming

    Novartis Vaccines

    Oversight of statistical analyses related SAS programming tasks as validation lead. Oversight of legacy data conversion related SAS programming tasks as validation lead. Development of project plans, validation plans and validation related documents such as IQ, OQ, PQ scripts, user requirement specification, functional specification, validation summary reports. Development of standard operating procedures (SOPs), work instructions and related documents.

  • 2007 - 2012

    Senior Statistical Programmer

    Novartis Vaccines

    Statistical analysis of clinical trial data in a senior role. Implementation of the CDISC-SDTM data standard. Conversion of legacy data into the CDISC data standard. Implementation of a clinical data repository. Other special, SAS programming related projects.

  • 2004 - 2007

    Bioanalyst

    Chiron Corporation

    Statistical analysis of clinical trial data.

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

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