Statistical Consultancy, Design and Analyses
Thorough planning and designing as well as a proper preparation of (clinical) studies with regard to statistical aspects (sample size/power calculations (using nQuery Advisor® & nTerim® as well as PASS®), statistical sections in protocols, analysis plans, randomisations with emergency envelopes if required) are essential prerequisites for a statistically sound evaluation with software in line with the industry standard (SAS®, Phoenix WinNonlin®, R) and the correct interpretation of results in a report and/or in a presentation.
Due to the activities as a biostatistician in a contract research organisation the experiences cover a broad range of indication areas. Specialising in consulting clinical researchers statistically focussing on early phase studies ("first in man" to "proof of concept", "pharmacokinetic"/-dynamic studies) was a consequence of the job as Director Biostatistics Clinical Pharmacology/Early Phase from 2004 to 2010.
As an independent person I can also offer my collaboration as an "Independent Statistician for Data Safety Monitoring Boards" according to international guidelines.
All functions/roles within Clinical Research, notably reliable PK performance, Data Management, Programming, Medical Writing, Regulatory, Pharmacovigilance Services and/or Clinical Supply Logistics may be easily integrated with highly experienced close-collaboration partners.
Support in statistics to be used in scientific papers like articles, theses, dissertations or other academic papers, advisory opinion to or quality control of third party statistical document as well as consultancy or trainings in particular statistical methods in clinical research are completing my service offers.