senior biostatistician associate director level basingstoke uk month fixedterm contract with strong possibility of extension senior authoring of statisticsmethods relating to study protocols randomisation sample sizes etc clinical trials results integration maa experience reporting to show clinical efficiency summary this is an excellent opportunity for an experienced senior biostatistician to secure a long term contract with a major pharmaceutical organisation the role encompasses all aspects of biostatistics in relation to the planning execution and reporting regarding clinical trials responsibilities the purpose of the role is to contribute to the product development strategy and serve as the project representative in registration and communication activities including communications with regulatory authorities this includes authoring statistical sections of protocol and statistical analysis plans provide leadership in biometric activities pertaining to clinical study projects provide in into the development of cdp and study design specification and review of draft randomisation schedules act as a primary sap author plus provide appropriate sample size calculations for specific objects of study designs in addition you will review statistical outputs act as the primary author of statistical methodology sections of study reviews and summary reports plus consult with medical writers physicians and support medical affairs the role is within a team of six statisticians with no direct reports education experience the successful candidate will be educated to at least masters level in biostatistics or a closely related discipline and off around 10 years experience in applying their skills to the planning running and reporting of clinical trials this should include senior authoring of statistics and methodologies relating to study protocols randomisation sample sizes clinical trials results integration and preferably maa experience keywords statistician senior statistician biostatistician senior statistician associate director of biostatistics nquery sas sap author this is a contract opportunity