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ABOUT US
We are a consulting company that provides services to the pharmaceutical and biotech industry. We are currently looking for 3-5 experienced biostatisticians with at least 3 years of clinical trials experience to work on long-term assignments with a leading biotech company in the San Francisco Bay Area. Telecommuting options available for qualified people.
DESCRIPTION
As part of a clinical development or assessment team, you will collaborate in the preparation and review of clinical assessments. Provides strategic input into the clinical development plan. For assigned clinical development project(s), provide sound strategic, statistical and scientific input on project objectives, experimental design, and data analysis to meet project needs and FDA statistical and scientific requirements. Review all project protocols, author protocol statistical analysis sections and generate study randomizations. Lead team's development of study analysis plans. Assume leadership for the Biostatistics activities related to portions of specific project(s). Review case report forms to ensure that protocol objectives are met and project standards are maintained. If a Biometrics Team Leader, plan and coordinate Biometrics team activities to ensure successful and timely completion of assigned projects. Author statistical analysis results in the clinical study report. See the report through review process. Represent Biostatistics group at FDA meetings. Respond to FDA questions and for statistical content of presentations at Advisory Committee Meetings. Assume statistical responsibility for major segments of a project, e.g. integrated safety/efficacy section of a BLA/NDA. Provide support for investigator publications. Encourage and contribute to discussion and preparation of publications and lectures on biometrics issues in clinical trials. Engage in research in statistics to improve clinical trial methodology used in the development of products consistent with corporate priorities and timelines.
HOW TO APPLY
If interested, please email your resume to danstar[at]iteinternational.com for immediate consideration.
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