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