Clinical Experience

Over 16 Years’ Experience in Clinical Research as Statistical Programmer Analyst and Biostatistician

Lead Statistical Programmer for “THOROUHG” QT/QTC Trial

Programming and Documentation of Analysis Data Sets (SDTM, ADaM)

Support Health Outcome Research for Epilepsy Drugs in Epidemiologic Area

Project Lead programmer of Japanese Submission for Epilepsy Trials

Lead Statistical Programmer for Trials Phase 3 and 4

Considerable Experience in planning, programming and performance of statistical analysis for phase I-IV clinical trials, observational studies and post-marketing studies

Support in Protocol Development, Writing of Statistical Analysis Plans, Analysis Programs, and Clinical Study Reports

Design and Conduct of Statistical Analysis (Bioequivalence testing, Generalized models, Non-parametric methods, Survival analysis, Meta-analysis)

Sample Size Calculation (using nQuery, SAS)

Providing Expertise for Scientific and Operational Aspects of a Clinical Study, Including Statistical Post-hoc/Add-hoc Analyses, Interim Analyses, and Analysis of a Series of Clinical Studies (e.g. Pooled or Meta-analyses)

Provided Programming and Statistical Support for Multiple Therapeutic Areas in Allergology, Cardiovascular Diseases, Gastroenterology, Gynaecology, Haematology, Immunology, Infectious Diseases, Inflammation, Neurology, Oncology, und Urology

Support and Assistance to Clinical Projects Related to Different Pharmaceutical Sponsors like Astellas, Allergan, Biotest, Bracco, Eli Lilly, Hoffman-La Roche, Merck, Reckitt Benckiser, Teva, UCB