
Senior Director, Biostatistics
Posted 1 day ago

Posted 1 day ago
This is a fully remote position, open to applicants in California, +1 more state.
• Contribute to both short-term and long-term Biostatistics strategies.
• Play a role in product development plans, global submission strategies, and the enhancement of infrastructure across Development functions and workstreams.
• Lead or provide support to teams across various disease areas, a therapeutic area, or other significant Biometrics domains.
• Consult with executives regarding future direction, investment prioritization, and strategic business choices.
• Direct complex, multifunctional programs and initiatives.
• Facilitate the integration, interpretation, and strategic utilization of data from a variety of internal and external sources.
• Act as a trusted advisor and strategic contributor to senior leadership.
• Develop subject-matter expertise within a specific therapeutic area, indication, or technical discipline.
• Convey scientific and statistical concepts to both internal and external audiences.
• Collaborate with Development and other functions to ensure alignment, decision-making, and effective execution.
• Manage a large, complex portfolio of programs and projects across multiple disease areas.
• Foster inclusion, nurture talent, and empower teams as a people leader.
• 12+ years of experience with an MS or PhD.
• 14+ years of experience with a BA/BS.
• Outstanding verbal and written communication skills.
• Comprehensive understanding of the drug development process.
• Strong dedication to Good Clinical Practice (GCP), ICH guidelines, and regulatory standards.
• Solid grasp of regulatory requirements and statistical principles.
• Excellent leadership, critical thinking, and strategic insight.
• Proven experience directing complex, multifunctional programs and initiatives.
• Demonstrated ability to integrate, interpret, and strategically employ diverse data sources.
• Experience in providing strategic direction to senior leadership.
• Subject-matter expertise in a therapeutic area, indication, or technical discipline.
• Expert-level knowledge of biostatistics and its continuously evolving landscape.
• Preferred: 15+ years of progressive industry experience with an MS or 12+ years with a PhD in biostatistics.
• Preferred: experience in advancing statistical analysis of biomedical data within complex development settings.
• Preferred: experience in leading biostatistics strategy for hematologic malignancies and solid tumors, especially in cellular and/or gene therapies.
• Preferred: leadership experience related to regulatory submission strategy, including advisory committees or oral presentations.
• Preferred: a history of publications.
• Preferred: capability to define and operationalize both short- and long-term biostatistics strategies.
• Discretionary annual bonus eligibility.
• Eligibility for discretionary stock-based long-term incentives may vary based on role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.
Amgen
Unitarian Universalist Association
Health Plans, Inc.
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