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Job #03557

About our client Our client is a rapidly growing CRO based in Pennsylvania that provides Regulatory, Clinical, Process Consulting Solutions to the biotech/pharma industry. The company has an experienced management team and an empowering corporate culture that is focused on the long-term professional development of it's employees. Position Location Sr. Clinical Biostatistician Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Participate in the design and review of clinical protocols and case report forms including preparation of statistical sections, sample size calculations, randomization and study design recommendations. 2) Prepare detailed statistical analysis plans (including shell tables and listings). 3) Provide detailed specifications to SAS programmers for generating SAS analysis datasets for efficacy and safety analyses. 4) Perform efficacy analyses to determine the difference in efficacy between test drug and controlled drug in clinical trials. 5) Perform safety parameter analyses to assess the safety profile of test drug compared to that of controlled drug in clinical trials. 6) Review study summaries and data displays for consistency with the statistical analysis plan and recommended approval or revision. 7) Provide advice and guidance to the data management and statistical programming team. 8) Coordinate data and table review activities among the project team. 9) Communicate with clients regarding study protocol and statistical analysis issues. Requirements 1) Ph.D. degree in Statistics, Biostatistics, Social Sciences, or other relevant academic field. 2) Minimum of 7+ years professional experience in a Life Sciences setting including 2-3 years working for a CRO (service provider) 3) Thorough knowledge of regulatory submissions process. 4) Strong writing, oral & presentation skills. 5) Knowledge of clinical trials conduct and the data and reporting requirements for clinical trials. 6) Knowledge of the practical application of principles, techniques, procedures and equipment used in the design and production of files, tables, listings, figures/graphs, edit checks, ad hoc programs, statistical analysis plans and efficacy / safety analysis.