The Regulatory Manager Vaccines is an integral member of the regulatory affairs team, leading registration of selected veterinary medicinal products for the global marketplace....
*Lead the development, assessment and introduction of new statistical technology and methodology (incl. statistical model-based drug development approaches using frequentist and/or Bayesian methodologies)*Provide statistical and strategic input in the writing of Statistical Analysis Plans (SAPs) and for pooling strategies for regulatory submissions.*Provides strategic input to the target patient value profile (TPP) and the clinical development plan including regulatory submission strategy and the life cycle of a development compound.*When needed, provide advanced statistical analyses to address complex design problems across therapy areas, for instance, performing complex simulations to determine sample size and power considerations for different study design options.*Reviews and approve abstracts, posters, presentations, and manuscripts for publication and ensures accuracy of all biostatistical aspects of such documents.*Effectively communicate complex issues in non-technical language by using visuals, simulations and other illustrative techniques*Keep abreast with ongoing developments in statistical methods applications in the pharmaceutical industry, both pre- and post-registration.*Provide statistical sciences training to people from different disciplines on advanced statistical concepts
*PhD. in Statistics or Mathematics is preferred (we would look at publications within your area of expertise)*Excellent understanding of the Clinical Trial process*10+ years' experience either in Pharma or in Academia*Expertise in statistical methodologies related to Clinical Trials: Bayesian Statistics, Adaptive Design etc.*Excellent communication and presentation skills*Good knowledge in either SAS or R programming*Provide training and guidance to team members in advance statistical topics*Be able to adapt to changing environments*Excellent Project Management skills*Knowledge the implications of the pharmacokinetic profile of a drug on the design of pharmacodynamics and Phase I-III studies
How to apply?
Send your CV to or call 0203 096 4701
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Clinical Trials, Drug Development, Statistical Methodologies, Late Phase, development compound, Statistical Innovation, Statistical Analysis Plan, Adaptive Design, Bayesian Statistics, SAS programming, R programming, study design, statistical modeling, UK, Belgium, Remote, Home-Based, Flexible working, Publications, Research, immunology, neurology, CNS, simulation, Data Analysis, Multivariate Data Analysis
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.