2012 - 2023: Team-Setup, Coaching, Mentoring, Leadership and Change-Management for department

Einsatzort: Munich

Rolle: Head of Biostatistics & Epidemiology

Kunde: GlaxoSmithKline

Aufgaben:

• Team-Setup, Coaching, Mentoring, Leadership and Change-Management for department (headcount: up to 4 FTEs, freelancers and students)
• Implementation and maintenance of standards for German HTA process (AMNOG)
• Cross functional collaboration on AMNOG-dossiers for various indications - together with Market Access, Medical Affairs, Regulatory Affairs and further local and global stakeholders from HEOR, Epidemiology, Biostatistics, Programming, Clinical Development, Pricing, Marketing
• Main tasks within HTA environment:
  • Evidence generation based on gap analysis
  • Literature and register review
  • Evidence analysis including meta-analysis, indirect treatment comparisons and analysis of Real-World Data
  • Development of dossier strategy
  • Shaping the HTA environment in Germany and EU by publications, presentations, reviews and by cross-industry collaborations
  • Interaction with external experts
  • Interaction with G-BA and IQWiG

• Biostatistical input to non-interventionalstudies (study design, analysis, publication of results)
• Inhouse consulting and training on biostatistics and epidemiology
• Outsourcing: development of strategy, vendor selection, vendor oversight
• Biostatistical input to Investigator-Initiated-Trials
• Conducting an internal medical advanced training series
• Member of Medical Leadership Team

2012-01 - 2012-04: Setup of AMNOG dossier processes

Einsatzort: Haar

Rolle: Senior Manager Outcomes Research

Kunde: MSD

Aufgaben:

• Development of AMNOG dossier strategy
• Evidence assessment and synthesis
• Biostatistical consulting

2005 - 2011: Strategic leadership for department

Einsatzort: Munich

Rolle: Head of Biostatistics / Data Management (Director)

Kunde: Fresenius Biotech GmbH

Aufgaben:

• Strategic leadership for department (headcount: 6 FTEs ? 2 Data Managers, 2 statisticians, 1 statistical programmer, 1 assistant)
• Implementation and maintenance of key processes and standards in Biostatistics and Data Management, ensuring GCP-compliance and allowing for sufficient flexibility
• Statistical support for European approval of catumaxomab as first drug worldwide to treat malignant ascites
• Representation of department at regulatory agencies (EMA, FDA, PEI)
• Accountability for all biostatistical and Data Management issues within dossiers, study protocols, statistical analysis plans, Data Management Plans, study reports, scientific papers, presentations
• Accountabilityfor global statistical development plans
• Accountabilityfor global strategic alignment of Biostatistics/ Data Management
• Implementation of EDC and related processes
• Continuous adaptation of interfaces to other departments (Clinical Operations, Clinical Development, Clinical Science, Drug Safety, Regulatory Affairs, Medical Affairs, Marketing and Sales, Preclinical, QM, IT)
• Accountabilityfor Input from Biostatistics / Data Management to project teams
• Coordination and Negotiation with CROs
• Standardisation of outsourcing-tasks
• Conducting internal / external trainings
• Supporting scientific marketing strategies
• Budget responsibility for department

1993 - 2005: Leading the Statistical Analysis Centre

Einsatzort: Munich

Rolle: Biostatistician

Kunde: Institute for Medical Statistics and Epidemiology Klinikum rechts der Isar, Technical University of Munich

Aufgaben:

• Setting-up and performing statistical services for the pharmaceutical industry and for other sponsors
• Leading the Statistical Analysis Centre for a multicontinental Phase-III-study in atherosclerosis
• Team Leader (2 statisticians, 1 statistical programmer)
• Statistical support for epidemiology studies, pharmaco-economic studies, meta-analyses, studies for medical devices
• Statistical consulting for medical projects
• Statistical Reviewer for several medical journals
• Statistical teaching for non-statisticians
• Fund raising

1991 - 1993: Planning, supervising and analysing clinical trials of phases II and III in cardiovascular indications

Einsatzort: Mannheim

Rolle: Biostatistician

Kunde: Boehringer

Aufgaben:

• Reporting and interpretation of statistical results for study reports and publications
  
• Statistical support for requests from regulatory authorities
• CRO-supervision and management
• Preparation of standard processes for statistical analyses
• Supervision of SAS-programmers
• SAS-programming

1989 - 1991: Programming the statistical analyses for clinical studies

Einsatzort: Mannheim

Rolle: SAS-programmer

Kunde: Boehringer

Aufgaben:

• Preparation and Validation of SAS-Macros
  
• Enhancement and optimization of SAS-Macros