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
  • Extensive Empirical Knowledge with PK/PD Trials
  • 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/Ad-hoc Analyses, Interim Analyses, and Analysis of a Series of Clinical Studies (e.g. Pooled or Meta-analyses)
  • 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, F.Hoffman-La Roche, Merck, Reckitt Benckiser, Teva, UCB 

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