Senior Director, Biostatistics jobs in United States
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SoTalent · 2 days ago

Senior Director, Biostatistics

SoTalent is committed to improving patient outcomes through scientific excellence and innovation. The Senior Director, Biostatistics provides enterprise-level leadership for statistical strategy and execution within a therapeutic area, influencing R&D outcomes and ensuring high-quality program execution.

Staffing & Recruiting

Responsibilities

Provide executive-level leadership for statistical delivery across development programs and portfolios
Act as a primary decision authority for execution and delivery matters impacting R&D outcomes
Define and implement strategies that enable consistent, predictable, and high-quality development execution
Identify delivery risks early and develop mitigation plans to protect timelines, quality, and investment
Build, scale, and sustain statistical delivery capabilities through effective processes, systems, and governance
Drive continuous improvement and innovation in delivery models, tools, and methodologies
Establish long-term vision for modernizing statistical execution and enabling future R&D needs
Lead and influence multidisciplinary teams across research, development, and operations
Represent the biostatistics function in senior-level internal forums and with external partners and vendors
Support regulatory interactions by providing strategic statistical input and leadership

Qualification

Advanced degree in statisticsLeadership in regulatory submissionsClinical trial design expertiseStatistical programming proficiencyPharmaceutical development lifecyclePeople leadership capabilitiesMatrixed environment influenceExceptional communication skills

Required

Advanced degree in statistics, biostatistics, or a related scientific discipline
PhD with approximately 12+ years of relevant experience, or Master's degree with approximately 15+ years of relevant experience
Demonstrated leadership in regulatory submissions (e.g., NDA, CTD, or equivalent)
Experience representing statistical perspectives in discussions with health authorities
Deep expertise in clinical trial design, analysis methodologies, and interpretation of results
Strong understanding of the pharmaceutical development lifecycle and cross-functional interfaces
Comprehensive knowledge of global regulatory standards and guidelines governing clinical research
Advanced statistical programming proficiency
Exceptional written, verbal, and executive-level communication skills
Broad statistical experience across multiple therapeutic areas or development phases
Strong people leadership, talent development, and organizational management capabilities
Proven ability to lead complex programs and influence outcomes in matrixed environments

Benefits

Short- and long-term incentive programs

Company

SoTalent

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At SoTechTalent, we specialise in connecting forward-thinking tech companies with world-class talent.

Funding

Current Stage
Early Stage
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