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US-Seattle-Washington: Senior Biostatistician

Date: 05-Apr-2011
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Senior Biostatistician

Accountable for the statistical input provided to all major documents, including clinical development plans, protocols, statistical analysis plans, clinical study reports, summaries of clinical safety and efficacy, and other sections of regulatory documents. Participates in FDA interactions, including FDA meetings, responses to FDA questions, and Advisory Committee Meetings. Builds strong relationships with clinical operations, regulatory, and commercial management in order to assist in defining strategic approaches to drug development and clinical trials and to meet operational requirements of development plans. Assists with setting goals and priorities for the department. Maintains comprehensive knowledge of theoretical and applied statistics, and regulatory guidelines regarding drug development strategies and clinical trial design, analysis, and reporting.

Qualifications and Requirements M.S. (prefer Ph.D.) in statistics/biostatistics or related field with at least 5 years of drug development experience, preferably with significant ophthalmology drug development. Comprehensive understanding of theoretical and applied statistics. Comprehensive understanding of regulatory guidelines in a pharmaceutical research setting. BLA/NDA development and submission experience required. Ability to effectively collaborate, with broad knowledge and perspective. Able to communicate, motivate, and influence throughout all levels of the organization. Ability to resolve and make judgments regarding administrative, scientific and/or clinical problems. Ability to prepare and deliver clear and concise statistical reports and presentations. Willingness to relocate to Seattle. Must be able to occasionally travel domestically and internationally as needed for business. Applicant must have current legal work authorization to work for any company in the United States.

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