Description
My client, a Paris based pharmaceutical company, are currently searching for a Biostatistician / Senior Biostatistician to join their growing team. This role has become available due to company growth and the success of their current projects - they currently lead an important clinical development program in oncology and in inflammatory and neurodegenerative diseases, with 10 Phase 2 studies on going in France and 13 Phase 3 studies underway in thirty countries.
As the Statistician / Senior Biostatistician, you will be responsible for the following:
-Write and revise protocols
-Provide statistical analysis of clinical trial: write the statistical analysis plan, program analyzes the statistics in SAS and perform quality control of clinical report
-Organize the committee review of the data base before freezing and un-blinding
-Participate in discussions with health authorities (MSNA, EMA, FDA) since the drafting of the Protocol to the registration dossier
-Validate the development and monitoring of randomisation tools (IVRS and IWRS), form project teams and users Profile
Experience and Education Required:
-Engineering degree with a specialization in statistics (Master 2, ENSAI ISUP ...)
-At least 5 years' experience in the field of statistics applied to medical research (pharmaceutical, CRO ...)
-Expertise essential SAS
-Mastery of the Windows environment; Capture System of knowledge is a plus
-Good writing skills in English
-Knowledge of international standards for statistical analysis (ICH) Modalities
For further details about this role or other opportunities within Biometrics please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk
