Principal Biostatistician

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Job description

Job Overview:Principal Biostatistician required to work for Labcorp Drug DevelopmentWorking with multiple Sponsors across several therapeutic areas in all phases of clinical trialsThis is a permanent full-time role, either office based or home based anywhere in EuropeYou must have previous experience of working as a Lead Biostatistician in either a biotech, CRO or pharma companyJoin our growing team and discover your extraordinary potential by working as a Labcorp Drug Development Principal Biostatistician. You will enjoy a varied role working for different sponsors across several therapeutic areas, leading projects and mentoring junior members of the department. The position offers an excellent support network with access to Labcorp Drug Development's statistical consultants, flexible working solutions and the opportunity to progress your career. If you are looking to strengthen your Lead expertise within a varied and dynamic environment, then this is a fantastic opportunity.Job Primary FunctionsLead complex studies such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetingsPerform project management activities for identified projects including resource planning, timelines and milestone managementServe as DMC Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical ConsultantsLead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticiansPerform complex statistical analyses, quality check statistical analyses developed by other statisticiansConduct overall statistical review of TFLs for complex studies prior to client deliveryReview CRF and other study specific specifications and plansPerform complex sample size calculations under the supervision of more senior statistical staffDevelop the statistical sections of the protocol for complex studies under the supervision of a statistical consultantProvide statistic input and review of the CSR for complex studiesPreparation and review of randomization specifications and generation of randomization schedulesProvide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and proceduresPresent and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferencesAttend bid defense meetings for complex studies such as NDA submissions or complex, multi-protocol programs in order to win new businessAct as Subject Matter Expert and develop or review procedural documents, or work on new initiativesRepresent the department during audits.Education/Qualifications:Master's degree, equivalent, or higher in Biostatistics or related fieldExperience:Previous experience of working as a Lead Biostatistician in either a biotech, CRO or pharma company.Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses. SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysisProven ability to effectively communicate statistical conceptsA good knowledge of the overall clinical trial processCompetence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trialsFluent in English language (both verbal and written).NO AGENCIES PLEASEMORE INFORMATION AVAILABLE ON REQUESTFor a confidential discussion about this opportunity, please phone Peter Lewis on (0) . To apply, please click on the APPLY button.Keywords:Labcorp Drug Development, Senior Biostatistician, Statistician, Medical Statistician, Clinical Statistician, Covance, Covance by Labcorp, Chiltern, Phases II-IV, Lead Statistician, Lead Biostatistician, Principal Statistician, Principal Biostatistician, SAP, Statistical Analysis Plans, pharma, pharmaceutical, SAS, home based, office based, office-based, home-based, flexible working, flexible location, home based UK Anywhere, anywhere in United Kingdom, UK, Great Britain, England, Scotland, Wales, Northern Ireland, Maidenhead, Berkshire, Austria, Belgium, Bulgaria, Czech Republic, France, Paris, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Leiden, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain. #LI-PL1, #LI-Remote, Remote, EMEA