Beschreibung
Based in Mainland Europe
£ Excellent Rate/hour
Accountabilities/Responsibilities:
Your responsibilities as a Study Statistician (phase 2 - IIIb):
* Planning and decision making about state-of-the-art study designs, evaluation methods and sample size calculations; developing study protocols in collaboration with study physicians; participating in the monitoring of study conduct to oversee data quality and potential implications for the planned analysis.
* Planning and controlling the entire study evaluation and reporting process through a statistical analysis plan; performing the inferential statistical evaluations
* Writing integrated reports and scientific publications, in collaboration with the study physician and medical writer
Your responsibilities as a Project Statistician (phase 2 - IIIb):
*Planning statistical aspects of clinical development plans, in close collaboration with the medical project leader and other members of the global project team. Providing answers to project related statistical or methodological questions from decision-makers inside and outside the company
* Writing detailed statistical project plans and stipulating requirements and standards for study teams; providing guidance to study statisticians on protocol development, analysis plans, study report, and publications.
* Planning and compiling clinical registration dossiers; preparing regulatory documentation for the EU and the USA, in collaboration with project physicians and data managers; discussing statistical issues with drug regulators.
Essential Skills & Capabilities:
You will be expected to have an MSc or PhD degree in statistics or mathematics as well as a comprehensive knowledge of biostatistics. You should also be familiar with the application of new statistical methods and theories in software solutions involving SAS or S-Plus. Experience as a project or study statistician in clinical development is considered a major advantage.
For further details or a confidential conversation please contact me directly:
James Carrera
Pharmaceutical Division
Statistics, Biostatistics & Programming
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