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Job #03657

About our client Our client is a CRO based in CA. They focus on providing services in data management, statistical analysis and study management. With an experienced management team, this is a great opportunity. Position Location Biostatistician II and I California Salary Highly competitive package, commensurate with experience Responsibilities 1) Analyze and summarize studies in support of product development and BLAs/NDAs 2) Write statistical analysis plans, create randomization schedules, review CRFs and data management plans, conduct statistical analyses and prepare statistical reports 3) Work with the SAS programmers and provide specifications of necessary analyses and summaries 4) Provide SAS programming support for the analysis databases and statistical reports and ensure the accuracy of the final result summaries produced by the SAS programmers 5) Review clinical protocols, case report forms and data management plans 6) Develop statistical analysis plans, randomization schedules, shells for tables, listings and figures 7) Prepare analysis dataset documentation, table shell annotation and CDISC ADaM and SDTM mapping documentation 8) Develop and execute QC programs for analysis datasets, tables and figures 9) Perform QC of listings, tables, figures and analysis datasets 10) Manage project timelines and communicate with clients regarding project deliverables 11) Deliver study output to clients 12) Prepare final study binders at completion of the study 13) Obtain signed approval of case report forms, data transfer specifications, randomization specifications 14) Determine appropriate statistical analysis methods to be utilized and appropriate data derivations 15) Ensure deliverables to clients are on time and have successfully passed QC processes 16) Work as a team member Requirements 1) MS/Ph. D. in Statistics 2) Minimum 2 – 4 years of experience in statistical analysis of medical research data 3) Practical and technical knowledge of statistical analyses in support of Phase 1 – 3 clinical trials or medical device studies 4) Experience in working with a major statistical software package such as SAS or S-plus 5) Strong statistical understanding 6) Excellent analytical, problem-solving, organizational, interpersonal and communication skills 7) Proficiency in various software applications such as MS Word and Excel 8) Demonstrated ability to effectively communicate to clients and to an internal Project Team 9) Ability to lead the team