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Director, Regulatory Data

3 months ago

London, Greater London, United Kingdom Planet Pharma Full time

The primary purpose of the Biostatistics Director is to act independently as Compound Statistician for complex work in an established area within clinical development.

This position may also act as Global Statistical Lead for an early or back up asset or as a Methodology expert validating the execution of complex techniques.

The role can be offered in #freelance basis for the right skills and experience.

Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports
Writing of the statistical methods sections of integrated study reports. Lead or supports responses to regulatory questions on the design of the program
PhD or M.S in Biostatistics, Statistics or related scientific field
Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to the statistical analysis of clinical data
Good ability in SAS required, knowledge of R preferred.