Emeryville, CA, 94662, USA
22 hours ago
Executive Director, Biostatistics
**General Description:** + A leadership position with opportunities to shape the future of BeiGene Statistics, providing high impact on development strategies and innovation in one or multiple areas. **Essential Duties & Responsibilities:** + Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for a therapeutic area. + Demonstrates ability to influence drug research & development strategic plans formulated with Senior Management. + Provide executive review for clinical development plan, protocol, SAP, CSR and other submission documents. + Review and approve responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators. + Oversee the research activities for innovative statistical methods and applications in clinical trial development. + Participates in company-wide standards discussions, finalization, and implementation. + Influence and provide good-faith challenge to the broader clinical organization with respect to clinical development decisions and data interpretation. + Manage groups of statisticians in a therapeutic area development in support of the ongoing trials and CDP development. + Liaise with other company function to influence, shape and drive unified strategies and rapid hypothesis generation and other relevant enterprise efforts. + Recruit, develop, and manage statisticians in the organization. **Qualifications:** + PhD or equivalent degree in statistics/biostatistics and 8+ years of relevant industry experience or a minimum of 14+ years of relevant work experience across multiple therapeutic areas, including 5 years managing a large global team. + Strong oral and written communication skills. + Experience with filings for major regulatory bodies and a good understanding of worldwide regulatory requirements. + Demonstrates a strong interest in statistical research activities and the application of novel methods to clinical trial development. + Thinks broadly, strategically, and timely when preventing, solving, or managing problems. + Prepared to make informed decisions and take calculated risks by thoroughly assessing situations and balancing priorities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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