Over 16 Years’ Experience in Clinical Research as

•    Statistical Programmer Analyst
•    Biostatistician

Statistical Programmer Analyst:

•    Programming and Documentation of CDISC compliant Datasets (SDTM, ADAM)
•    Creation and Validation of Analysis Database
•    Generation of Tables, Listings, Figures (TLF) Shells
•    Lead Statistical Programmer for „THOROUGH“ QT/QTC Trials
•    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 III – IV

Biostatistician:

•    Considerable Experience in Planning, Programming and Performance of Statistical Analysis for
  •     – Phase I-IV Clinical Trials
  •     – Observational Studies
  •     – 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
  •     – Analysis of a Series of Clinical Studies (e.g. Pooled or Meta-Analyses)    

Support and Assistance to Clinical Projects related to Different Pharmaceutical Sponsors:

•    Astellas, Allergan, Biotest, Bracco, Eli Lilly, F.Hoffman-La Roche, Merck, Reckitt Benckiser, Schwarz Pharma, Teva, UCB  

  Programming and Statistical Expertise in the following Therapautic Areas:

•     Allergology
•     Cardiovascular Diseases
•     Dermatology
•     Gastroenterology
•     Gynaecology / Obstetrics
•     Haematology
•     Immunology
•     Infectious Diseases
•     Inflammation
•     Neurology
•     Oncology
•     Urology 

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