Description
Expert Statistical MethodologistWorking for one of Cambridge's most prestigious Pharma companies, your role as statistical methodologist ensures the effectiveness of leading edge statistical methods are used to support clinical trials and projects.
Providing support and guidance to biostatisticians focusing on the development, implementation and execution of leading edge methodology.
Role and responsibilities:
Planning of clinical projects across all phases of clinical trials utilizing cutting edge designs and established methods.
Identify and execute statistical opportunities for statistical innovation and forecasting
Develop dedicated methods evaluated by appropriate means, ie statistical modeling, simulation and new analytical tools.
Participate in non-clinical project activities and bridge the gap between clinical / non clinical R&D teams.
Understand health Authority requirements SOPs, NIPs, Master Analysis plans, GCPs and Regulatory guidelines
Lead the writing and updating of new internal processes and guidance documents with a mythological emphasis.
Experience required
PHD in statistics or biostatistics
5+ years biostatistics experience within a Pharma or biotech environment
Understanding of POC / Phase I clinical trials
Expert knowledge of statistical methods and innovative statistics to be applied within a drug development environment.
Excellent communication skills
SAS / R programming skills
Understanding of HA guidelines relating to statistical methods within drug development
To find out more about Real please visit www.realstaffing.com