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The Biostatistician 1 will participate in one or more project teams. Prepare analysis plans and write detailed specifications for analysis files, consistency checks, and tables/figures/listings. Write statistical section of study reports and provide general statistical analysis support for project teams.
• Develop analysis plans, table shells, programming and table specifications; produce tables, listings and figures; perform data review and statistical analysis.
• Assist with protocol development, sample size calculation, and protocol and case report form (CRF) review.
• Advise data management staff on database design, validation checks and critical data.
• Assist in writing statistical sections of integrated reports.
• Assist project lead in fulfilling project responsibilities.
• Under supervision, manage project budget and resource requirements. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies.
• Provide training and guidance to lower level and new staff.
• Masters degree or educational equivalent in biostatistics or related field.
• Strong aptitude for and strong working knowledge of SAS computing packages
• Familiarity with basic statistical methods that apply to Phase I-IV clinical trials
• Ability to effectively manage multiple tasks and projects and accept direction of lead team members
• Excellent organization and communication skills
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