Dear Allstat



 



Key People are currently recruiting for a Senior Expert Statistician to work in their international oncology team based in Switzerland.



You will work as the statistical leader and project manager for all Biostatistics and Statistical Reporting deliverables globally for a clinical development program and will also work as part of the Global Project Team to ensure that clinical development program meets scientific, regulatory, quality and commercialization requirements. 

Set up in a matrix management structure you will supervise biostatisticians on the project team. 

Ensure that statistical expertise from Early Clinical Development, Clinical Pharmacology and Modeling & Simulation is fully integrated into the project. 

Plan and track project level activities, including resources. 

Establish and maintain project standards. 

Plan and manage submission activities 



Interaction with Health Authorities and external consultants as appropriate. Support and defend analyses and their interpretation at Health Authority Meetings. Represent Biostatistics at FDA Advisory Committee meetings. 

Could take Indication or Trial Statistician responsibility as appropriate.



Candidates applying should have the following: 



Masters Degree in Statistics (or equivalent degree) with at least 7 years of pharmaceutical experience or a PhD in Statistics with at least 4 years of pharmaceutical experience 

Experience in all Project Statistician tasks with at least 2-4 years experience

Proven knowledge and expertise in statistics and its application to clinical trials in at least one therapeutic area (preferably Oncology) 



Candidates must be currently resident in the EU 



Solid knowledge and experience in drug development process and guidelines 

Fluent English (oral and written) 

Proven Knowledge and expertise in statistics and its application to clinical trials 

Proven knowledge of drug development and Health Authority guidelines 

Knowledge of statistical software packages (e.g. SAS, S+) 

Very good project management skills 

Very good communication and presentation skills 

Good leadership skills. Ability to give effective guidance to Trial Statisticians and Project Programmer



 



 



If you would like to apply for this position please contact Ilan Lynton at Key People by sending your CV in a Word format to [log in to unmask] or call Ilan on +44 (0) 1727 817 626



 



Kind Regards



 



 



 



Ilan Lynton



Recruitment Resourcer 



 



Key People Ltd.



Catherine House / Adelaide Street / St. Albans / Herts. / AL3 5BA



 



Direct Tel: +44 (0)1727 817 626 (ddi) / Switchboard Tel: +44 (0)1727 811 634 / Fax: +44(0)1727 844 838



Email: [log in to unmask] 



LinkedIn Profile: http://uk.linkedin.com/in/ilanlynton <http://uk.linkedin.com/in/ilanlynton> 



 



Refer a friend and get paid



 



At Key People many of the people we place have been referred to us by their friends and colleagues. If you refer someone to our division and we are able to help them secure employment, then after successful completion of the probation period, we will reward your efforts with a 'thank you’ for £250 (or currency equivalent).