Carsten Schwenke

• Clinical: statistical design and planning of clinical development programs and clinical studies.
• Non-clinical: statistical experiment design.
• Statistical data analysis.
• Statistical support for submissions to and negotiatings with health authorities (EMEA, FDA).
• Statistical support for due-dilligences.
• Independent statistician in data monitoring boards.
• Support for benefit dossiers acc. to German AMNOG (Nutzendossiers für die frühe Nutzenbewertung nach § 35a SGB V) with regard to strategy, analysis plans, analyses, interpretations, preparation of modules 1 and 4, supporting advice meetings, written statements and oral hearings.

Dr. Carsten Schwenke, the founder of SCO:SSiS Statistical Consulting, started as statistician in the pharmaceutical industry in 1997. He gained working experience at Chiron Behring GmbH, Schering AG and Bayer Schering Pharma AG. He headed the statistics group at Chiron Behring and worked in global project teams. In 2007 he founded his own consulting company.

His positive track record consists of several successful European Marketing Authorizations in the field of Vaccines and Diagnostic Imaging. He supported various disciplines like pre-clinical and clinical research and development, production and was responsible for the statistical aspects of several European and global development programs. He has a firm knowledge of the regulatory requirements and guidelines. His experience within clinical development includes phase I-III and post-authorization activities. He also gained deep insight into Health Economics and Outcomes Research. Since 2011 he is heavily envolved in the benefit assessment according to the German AMNOG.

His key activities and services are:

• Statistical support in the planning, conduct and analysis of clinical studies and development programs
• Statistical strategy planning (global clinical development plans, protocol development)
• Statistical support in the planning and analysis of in-vivo and in-vitro studies
• Support in the preparation of dossiers for marketing authorizations and within the approval process at the EMEA and FDA
• Evaluation of all statistical aspects within due-dilligences
• Independent statistican in data monitoring boards
• Support for benefit dossiers acc. to German AMNOG (Nutzendossiers für die frühe Nutzenbewertung nach § 35a SGB V)

Certificate "Biometry" of the University of Dortmund, Germany.

Education:

Studies in statistics (Diplom-Statistik) at Universities of Dortmund, Sheffield and Göttingen with minor topic Medicine (University of Bochum)
PhD in Public Health (Technical University of Berlin)

Experience:

Broad statistical and industry background (~10 years as statistician in the pharmaceutical industry).

Main indications include vaccines, diagnostics, oncology, specialized therapeutics.

Positions before starting freelance consulting activities in 2007 include head of statistics group (clinical and non-clinical statistics), Chiron-Behring GmbH; study and project biostatistician, Schering AG; health economics project leader specialized therapeutics, Schering AG

Since 2011, he supported companies in preparing benefit dossiers according to the German AMNOG. Up to end 2014, he was envolved in more than 20 dossiers and participated 10 oral hearings at the FJC (Gemeinsamer Bundesausschuss).

Areas of Expertise:

Statistics