Beschreibung
Based in Mainland Europe
£ Excellent Rate/hour
Your responsibilities as a Biostatistician (phase II - IIIb):
* Planning statistical aspects of clinical development plans, in close collaboration with the project statistician and other members of the global project team.
* Assist in the writing of protocols, SAP's, validation of analysis programs and QC
* Participate in the monitoring of study conduct to oversee data quality and potential implications for the planned analysis.
* Collaborate with the lead programmer, contributing towards the validation of statistical programs for trial analysis.
* 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 At least 4 years experience in Phase II-IIIb international clinical development.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 as well as therapeutic experience within metabolism or diabetes.
For further details or a confidential conversation please contact me directly:
James Carrera
Pharmaceutical Division
Statistics, Biostatistics & Programming