CONTRACT: Senior Biostatistician - Phase II-III - 12 months based in France
£ Excellent Rates / hour


Job Summary:

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. Apply yourself as both a project and study statistician in clinical drug development, a challenging and rewarding position that awaits you

Accountabilities/Responsibilities:

Your primary responsibility will be to work as statistician in the clinical development of new drugs - from registration to launch. The job involves working closely with physicians, data managers and programmers in international project and study teams.

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.

An excellent opportunity awaits for this renewable contract. Interview times booked and full job specification to review...

For a confidential consultation call James Carrera on 0044 (0) 207 255 6665 or email your CV to [log in to unmask]

James Carrera
European Contracts Manager
Pharmaceutical, Healthcare & CRO division

1st Pharma People
"A Division of 1st IT People"
Tel: +44 (0) 207 255 6665
Fax: +44 (0) 207 255 6656
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www.1st-pharmapeople.com

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