Regulatory Statistician

Regulatory Statistician / Biostatistician

This is an ideal opportunity for an experienced clinical trials statistician to increase their regulatory knowledge and work at the cutting edge of drug development submissions. The successful candidate will oversee the statistical ethics of multiple drug development projects concurrently.

Responsibilities:

• Interating with medical assesors, the statistician will be ensure the integrity of data and statistical methodologies used at different stages of a drug development submission.
• Assess all documentation and produce critical appraisals of the outcomes and methods used. Advise pharmaceutical companies on clinical trial design, methodology for attaining data and consistency of data in relation to license applications.
• Keep up to date with new statistical methodology and techniques. Reporting to changes so that regulatory guidelines can be adjusted appropriately.
• Provide statistical training and advice to regulatory assesors

Skills / qualifications

• MSc or PhD in a statistics related discipline
• Knowledge of clinical trials phases 1 – 4
• Experience of trial design, analysis and interpretation
• Excellent communication skills
• The ability to work to tight project deadlines

For immediate consideration send your CV to [Email hidden] or call 0207 255 6600 and ask for Simon Boorman.

Keywords: Statistician, biostatistician, regulatory, phase I, phase II, phase III, phase IV, SAS, SPSS, London, Homes counties, Surrey, Berkshire