Principal Biostatistician, Senior Statistical Programmer Analyst – Independent Contractor
Services
I offer Clinical Programming and Statistical Support in Clinical Research and Development Phase as well as Post-Marketing Phase across Various Therapeutic Areas
Clinical Research
I have supported Clinical Studies since 2002 as a Statistical Programmer and have also been involved in Several Submissions for FDA, EMA and PMDA
Statistical Programming
I can provide Statistical Solutions and Expertise for Supporting Planning, Design and Analysis of Clinical Trials offering a Variety of Services
Biostatistics
I offer Statistical Support for Clinical Research / Development Phase and “Post-Marketing” Phase:
Phase I-IV Clinical Trials
NIS / PASS Studies
Thorough QT / QTc Trials
HTA Trials
Including a Broad Range of Clinical Statistical Services:
Statistical Input into Study Protocols
Sample Size / Power Calculation
Statistical Analysis Plan (SAP)
Preparation of TFL (Tables, Figures, Listings) Shell for Clinical Trial Reports according to ICH Guidelines