
Position Description
Executive Director, Biostatistics
Location
Remote
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Position Summary
The Executive Director, Biostatistics leads the design, development, and evaluation of statistical and technical components that drive the efficient execution and analysis of clinical trials. Serving as the lead statistician on assigned studies, this role provides senior-level statistical expertise and strategic guidance to the Biometrics function.
Essential Duties & Responsibilities
Strategic Leadership
Provide strategic direction for the statistical function, establish performance objectives, and ensure adequate statistical support across all project teams.
Work effectively with complex and abstract concepts across multiple business functions, evaluating intangible variables to identify fundamental issues and set strategic direction for major functional areas.
Keep senior management informed of progress, risks, and issues affecting project and organizational objectives.
Clinical Trial Design & Analysis
Provide leadership and oversight to ensure the statistical integrity of clinical trial design, data analysis, and reporting.
Guide the development and application of innovative clinical trial designs to improve operational efficiency and support drug development objectives.
Provide statistical leadership for regulatory submissions, clinical development plans, and out-licensing activities, proactively identifying and resolving issues arising during study conduct.
External Partnerships & Standards
Build and maintain external relationships with academic and regulatory statisticians, including FDA partners, to support regulatory strategy and best practices.
Oversee the development, maintenance, and application of departmental processes, standards, and SOPs.
People & Resource Management
Manage and develop statistical staff through mentoring, recruiting, performance management, and goal setting.
Own departmental budgeting and resource planning.
Perform other related duties as required.
Qualifications & Experience
Education
PhD in Biostatistics or a related field, or an MS in Biostatistics, required.
Experience
12+ years of relevant experience with a PhD, or 15+ years with a Master’s degree.
Minimum of 6 years of direct people management responsibility.
Demonstrated experience leading statistical strategy for NDAs, BLAs, and PMAs.
Technical Expertise
Deep expertise in adaptive clinical trial designs and advanced statistical methodologies, supported by an established publication record in innovative trial design and statistical methodology.
Extensive experience with FDA and ICH regulatory frameworks and guidance.
Expert proficiency in SAS, with demonstrated ability to leverage complementary statistical tools as appropriate.
Advanced capability in evaluating and guiding technical solutions across statistics, programming, and data management.
Leadership & Communication
Proven ability to influence and advise senior leaders and external stakeholders.
Strong organizational and portfolio-level execution capabilities.
Exceptional written and verbal communication skills.
Demonstrated leadership in building, developing, and sustaining high-performing teams.
Health Insurance (Medical/Dental/Vision)
Disability Insurance
Holiday Pay
Paid Time Off (PTO)
401(k) Match
Employee Stock Purchase Plan
Wellness Programs
Parental Leave Benefits (in accordance with the terms of applicable plans)
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Originally posted by Nektar Therapeutics. View original posting
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