Statistician, Regulatory Agency (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 nuwan@srgir.co.uk with
datashaping.com as reference
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