Principal Biostatistician, Senior Statistical Programmer Analyst – Independent Contractor
Our work
Clinical Experience
Projects Related to Different Pharmaceutical Sponsors for which I have worked include Astellas, Allergan, Biotest, Bracco, Eli Lilly, Hoffman-La Roche, Merck, Reckitt Benckiser, Teva, UCB... Read More>>
Different Pharmaceutical Sponsors
I have provided Statistical Support for Multiple Therapeutics Areas in Allergology, Cardiovascular Diseases, Gastroenterology, Gynaecology & Obstetrics, Haematology, Immunology, Infectious Diseases, Inflammation, Neurology, Oncology, und Urology... Read More>>
Multiple Therapeutics Areas
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: