Lead Statistician - Phase II - III South East, UK
£ Excellent Rate / hour - Dependant on Experience
6 month rolling project
For a confidential consultation call James Carrera on 0044 (0) 207 255 6665 or email your CV to [log in to unmask]
Are you looking for a challenging job that will allow you to apply and develop the knowledge and skills you have acquired during your studies and in practice, and to do so in an international environment?
Then join one of the most reputable and highest ranking research-based pharmaceutical corporations in the world.
Your primary responsibility will be to work as statistician in the clinical development of new drugs - starting from phase II up to registration and launch. The job involves working closely with physicians, data managers and programmers in international projects and study teams.
* 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
*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.
You must have 5-8 years solid experience as a statistician / biostatistician in the Pharmaceutical, Biotech or CRO industry.
Although this is a multiphase role, Oncology experience is highly desirable
Manager - Pharmaceutical, Healthcare & CRO Division
Tel: +44 (0) 207 255 6665 [log in to unmask]
Fax: +44 (0) 207 255 6656
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