Ref: 1011/11a
FREELANCE: Senior Statistician
12 months rolling contract
UK, South East
For a confidential consultation call James Carrera on 0044 (0) 207 255 6665 or email your CV to [log in to unmask]
START DATE: ASAP, but they will wait for the right candidate / notice periods.
Summary:
The role of the Senior Statistician is to enable optimum statistical support for all clinical trials performed in or under supervision of the Global Medical Affairs organization, through supervision of external statistics and data management services and ensuring timely and qualitatively excellent preparation and delivery of statistical analysis results.
Requirements:
Will assume primary responsibility for some of the following tasks:
- 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
Your qualifications
* 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.
James Carrera
Pharmaceutical Division
Manager - Statistics, Biostatistics & Programming
Tel: +44 (0) 207 255 6665
[log in to unmask]
http://uk.linkedin.com/in/jamescarrera
Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics, statistician, biostatistics, biostatistician
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