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• Perform, advise, and review protocol development, sample size calculation, protocol and CRF review.
• Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data).
• Fulfill the Lead role for a group of studies or integrated summaries.
• 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 groups of studies.
• Lead the review of RFPs and QIPs; prepare proposal text and attend bid defense meetings for single studies.
• Manage customer relationships and provide training and guidance to lower level and new staff.
• PhD or educational equivalent in biostatistics or related field and 3 years relevant experience; Master's degree or educational equivalent in biostatistics or related field and 5 years relevant experience.
• Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials
• Strong working knowledge of SAS computing package
• Familiarity with other statistical computing packages such as S+, SUDAAN, StatXact
• Pharmaceutical, drug development, biotech or CRO industry experience
• Excellent written and oral communication skills including grammatical/technical writing skills
• Excellent attention and accuracy with details
• Strong individual initiative, organization skills and multi-tasking ability.
• Ability to lead and co-ordinate small teams
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