This job is no longer available
South East, UK
12 Months +
£50 - £60 P/H
- Advice on statistical and scientific issues like project plans, study design, sample size calculations.
- Statistical component of study protocols, either indirectly by reviewing and approving documents (primarily), or directly for high priority or complex regulatory submission programmes.
- Statistical analysis plan, either indirectly by reviewing and approving documents (primarily) or directly for high priority , complex regulatory submission programs
- Advice to statistical programmers in order to establish strategy and deliver statistical results for clinical studies
- Statistical component of study reports, either indirectly by reviewing and approving documents (primarily) or directly for the most complex and high priority regulatory submission programmes.
- Planning, analysis and reporting for regulatory submissions, in particular integrated summaries, either indirectly or directly
- Statistical contribution to ISS and ISE, either indirectly or directly.
- Scientific and business oversight of the consulting team.
- Direct contribution to study protocol , analysis plans, reports and submission documents will be limited to most complex and high importance regulatory submission projects.
- Deputize for Director, Biostatistics, as required
PhD or MS in Statistics with Five years of experience
NDA submission experience, preferred.
Experience with data integration is a must.
Candidate must be capable in SAS programming and will be expected to do some validation programming.
The candidate will be working with statistician and programming colleagues.
Consumer Health Experience advantageous
If you would like a confidential discussion in regards to this exciting opportunity, then please feel free to get in touch on +44 207 255 6665 OR alternatively send your updated CV to firstname.lastname@example.org for immediate consideration
Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics, statistician, biostatistics, biostatistician