Statistician
Salary: On Application
Location: London
Exciting new opportunity for an experienced Statistician to work for a leading Regulatory Agency based in London.
A Regulatory Agency based in London is seeking to employ an experienced Statistician to review marketing authorisation applications and advise on good drug development.
Main Accountabilities:
* Assess evidence of efficacy in marketing authorisation applications. Assessments should be performed using appropriate guidelines and according to agreed deadlines.
* For each CHM meeting, review the CHM papers for an agreed set of applications and provide briefing comments on schedule.
* Advise pharmaceutical companies on good clinical trial design, statistical methodology and adequacy of data relating to licence applications in UK and CHMP scientific advice procedures.
* Contribute to the development of CHMP and ICH Guidelines as required according to agreed deadlines.
* Keep abreast of new statistical methodology. Ensure maintenance of computing and analytic skills by occasional analysis of datasets.
* Provide training and advice in statistics for assessors from other disciplines.
* Participate in external conferences and meetings to help maintain the high profile of the company Statistics Unit.
Background:
* MSc or PhD in Statistics or closely related degree.
* Knowledge of the pharmaceutical industry and regulatory practises/guidelines.
* Proven experience in the design, analysis and interpretation of clinical data.
* Excellent written and verbal communication skills.
* MUST BE ELLIEGLE TO WORK IN THE UK.
Key skills:
* Clinical Experience
* Experience in Regulatory Affairs
For more information, please contact Nuwan Wanigasekera on 0207 562 1794, or email [log in to unmask]
**********************************************************************
This email and any files transmitted with it are confidential and
intended solely for the use of the individual or entity to whom they
are addressed. If you have received this email in error please notify
the system manager.
This footnote also confirms that this email message has been swept by
MIMEsweeper for the presence of computer viruses.
**********************************************************************
______________________________________________________________________
This email has been scanned by the MessageLabs Email Security System.
For more information please visit http://www.messagelabs.com/email
______________________________________________________________________
|