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You will be working for a leading international diagnostics company based in the Bay area – Northern California. (12 month contract - Possibility of direct hire). You will be required to work as a lead on clinical development plans, the design and conduct of clinical studies and in the evaluation, interpretation and preparation of study results. As a lead in the clinical assessment team you will: • Collaborate in the preparation and review of clinical assessments. • Provide statistically sound experimental design and data analysis input to meet project objectives and FDA statistical requirements. • Review all project protocols, author protocol statistical analysis sections and generate study randomizations. • Develop study analysis plans as a team member; lead this effort for selected studies. • Review case report forms to ensure that protocol objectives are met and project standards are maintained. • Develop statistical programs as necessary to perform analyses, prepare data displays, and verify data accuracy and validity. • Author statistical analysis results in the clinical study report. • Responsible for seeing the reports through the review process. • Supply statistical input for BLA submissions and in response to FDA questions. • Provide support for investigator publications. Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, workshop attendance, etc. In order to be consider, you should have experience with statistical software packages such as SAS and S-Plus. A sound knowledge of theoretical and applied statistics. A sound understanding of regulatory guidelines in a pharmaceutical research setting. You should have effective communication skills and be a strong team contributor. EDUCATION: Ph.D. in statistics/biostatistics with at least 2 years of clinical trials experience or a Master's Degree in statistics/biostatistics with at least 5 years of clinical trials experience. If you do not meet the above requirements but are interested in working in California – please call for general discussion. Suzannah Austen-Adams Bioinsource Calling From: UK: 0845 634 0505 Europe: + 44 1666 840 323 USA:1 888 602 1864 ______________________________________________________________________ This email has been scanned by the MessageLabs Email Security System. For more information please visit http://www.messagelabs.com/email ______________________________________________________________________