Senior Director, Biostatistics

Senior Director, Biostatistics at SoTalent Senior Director, Biostatistics at SoTalent in Milton Village, Massachusetts Posted in about 22 hours ago.

Type:

full-time

Job Description:

Senior Director, Biostatistics Location:

Boston, MA Role Purpose This organization is driven by a commitment to improving patient outcomes through scientific excellence and innovation. Data, analytics, and quantitative rigor are central to how research and development decisions are made, enabling faster progress, stronger evidence, and more predictable delivery of new medicines. Within the R D organization, a global quantitative sciences function provides strategic leadership across areas such as biostatistics, quantitative pharmacology, programming, real-world evidence, patient safety, and operational strategy. This group integrates advanced analytics, statistical methodology, machine learning, and modern data platforms to guide development decisions across the discovery, preclinical, translational, and clinical continuum. Position Overview The Senior Director, Biostatistics provides enterprise-level leadership for statistical strategy, execution, and delivery within a therapeutic area, business unit, or specialized quantitative function. This role carries accountability for influencing R D outcomes, shaping delivery models, and ensuring high-quality, timely, and efficient program execution. The position serves as a key decision-maker and cross-functional leader with direct impact on development strategy and operational success. Key Responsibilities Strategic Leadership & Delivery 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 Organizational & Capability Development 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 Cross-Functional & External Engagement 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 Required Experience & Expertise 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 Leadership Attributes Successful candidates will demonstrate the ability to: Inspire, motivate, and develop high-performing teams Lead with confidence while fostering collaboration and inclusion Balance strategic vision with operational execution Drive alignment and accountability across diverse stakeholder groups Compensation & Benefits Estimated Base Salary Range (Boston, MA): $208,200 - $327,140 Final compensation will be determined based on experience, education, role scope, geographic location, and other relevant factors, in accordance with applicable laws. In addition to base pay, this role may be eligible for short- and long-term incentive programs.

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