Director, Biostatistics (BME)
Job Location: San Francisco, CA.
Statistical leader to interface with Regulatory Authorities, working with regulatory queries, and ensuring the generation of high-quality clinical trial data to aid in decision making. Lead protocol design and clinical trial data analysis, statistical analysis plans and statistical methodology sections of protocol. Oversee programming support and any outsourced biometric responsibilities. Direct the development, review and approval of SOPs and CRF design. Prepare & provide written reports, presentations and publications. Direct the activities of biostatistics projects with responsibility for results with relationship to cost, methods and employees. Responsible for providing regular performance feedback, development and coaching to direct reports.
PhD in a Statistics related discipline. 10 years’ experience in statistics in the pharmaceutical industry. 7 years’ experience with direct reports, people management. Strong Project Management experience. History of submissions and positive interactions with the FDA and other Health Authorities. Ability to create and manage internal/external business relationships representing the client in a highly professional manner.
Please contact Bill Emker at firstname.lastname@example.org
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