For a confidential consultation call James Carrera on 0044 (0) 207 255 6665 or email your CV to [log in to unmask]
Ref: 114/11c
Project Statistician - Phase I - IIIb
12 month rolling contract
Mainland Europe
Job Summary:
Your primary responsibility will be to work as a statistician in the clinical development of new drugs - starting from phase I up to registration and launch. The position involves working closely with physicians, data managers and programmers in international project and study teams.
Accountabilities/Responsibilities:
* 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 reports 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 R. Experience as a project or study statistician in clinical development is considered a major advantage.
You will be expected to be self motivated, a good communicator and team player, have a firm grasp of the English language, and enjoy working on challenging scientific projects and studies in an international setting.
For further details or a confidential conversation please contact me directly:
James Carrera
Manager - Statistics, Biostatistics & Programming
Pharmaceutical, Healthcare & CRO Division
Tel: +44 (0) 207 255 6665
[log in to unmask]
http://uk.linkedin.com/in/jamescarrera
Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics, statistician, biostatistics, biostatistician
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