Senior Statistician II Location:Boston The Senior Statistician II has sufficient experience working as a statistician in the pharmaceutical industry to be working independently on activities relating to design, delivery and interpretation, regulatorysubmissionsand/or commercialisation. This individualis able toperform and communicate results of more technical analyses, and able to guide less experienced staff. They have the scope to develop creative statistical ideas and approaches, and to apply them in their work. Competent individual contributor with excellent cross-functional collaboration. Typical Accountabilities The Senior Statistician IIwillwork directly within a project. The accountabilities for supporting projects directly are: • Provide statisticalexpertisefor complex design and interpretation for clinical programmes, high level internal governance committees, regulatorysubmissionsand/or commercialisation • Analyse internal and external information, perform modelling and simulation to inform design decisions and the development of decision criteria • Develop a Statistical Analysis plan for complex studies and/or project deliveries • Act as a coach/guide for less experienced statisticians in the production of analysis, supporting graphics and analysis tables for study reports, Global Medical Affairsstudiesor publications • Able to analyse, interpret,summariseand communicate results of complex studies • Contribute to the regulatory submissions including specification of overview documents and response to regulatory questions •Identifyopportunities for the application of modelling and simulation to improve study design •Identifyopportunities to improve themethodologyand provide practical solutions for problems •Identifyand apply statisticalmethodologyto improve the process and delivery activities • Contribute to the development of best practice to improve quality,efficiencyand effectiveness • Accountable for the quality of their statistical work; provide discipline-specific understanding, insight and constructive challenge and take ownership of development needs, seek coaching or training opportunities Education, Qualifications,Skillsand Experience Essential • MSc/PhD in Statistics, Mathematics (containingasubstantialstatisticalcomponent), or recognised equivalent to stats MSc . 3+ yrs experience of pharmaceutical development, dataanalysisand interpretation. • Competent statistical programmer (SAS and R) • Knowledge of key technical and regulatory requirements • Experience of design,analysisand reporting of clinical studies in more than one setting • Communication skills • Collaboration and team working skills • Experience and knowledge of statistical methods and applications in study design,analysisand interpretation Desirable • Collaborationskillsrequired • Ability to apply statisticalexpertiseto problems, problemsolvingand quality focus Global job code #J-18808-Ljbffr
Senior Statistician Ii - Biostatistics
ASTRAZENECA
gaithersburg, gaithersburg
Published 4 days ago
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