Senior Director, Biostatistics

Key Responsibilities

• Provide statistical leadership and strategic guidance across one or more clinical development programs from protocol concept through regulatory submission and post-hoc analyses.
• Lead statistical contributions to study design, including endpoint strategy, estimands, randomization methodology, multiplicity adjustments, interim analyses, and sample size determination.
• Author, review, and approve statistical sections of protocols, statistical analysis plans (SAPs), clinical study reports (CSRs), regulatory briefing documents, publications, and other study-related deliverables.
• Oversee development, validation, and review of statistical outputs, tables, listings, and figures to ensure quality, reproducibility, traceability, and regulatory compliance.
• Ensure statistical analyses and deliverables meet internal quality standards as well as applicable regulatory expectations and industry best practices.
• Partner closely with cross-functional study teams to support data review, interpretation of study results, risk assessment, and decision-making throughout the clinical development lifecycle.
• Lead and manage relationships with external CROs, biostatistics vendors, and programming partners, including scope definition, timelines, budget oversight, quality management, and performance monitoring.
• Support global regulatory interactions, including preparation for Health Authority meetings, submission activities, and responses to regulatory questions.
• Contribute to the development and implementation of departmental standards, processes, statistical methodologies, and operational best practices.
• Hire, mentor, coach, and develop biostatistics talent as the organization continues to scale.
• Serve as a strategic thought partner to senior leadership and contribute to broader organizational and portfolio-level initiatives.

Qualifications

• PhD or MS in Biostatistics, Statistics, or related quantitative field with significant industry experience in biotechnology or pharmaceutical drug development.
• Typically 12+ years of relevant biostatistics experience within the pharmaceutical, biotechnology, or CRO industry, including leadership responsibility supporting clinical development programs.
• Demonstrated experience supporting clinical studies across multiple phases of development, including late-stage studies and regulatory submissions.
• Deep understanding of clinical trial methodology, statistical principles, regulatory guidance, and industry standards applicable to drug development.
• Strong experience authoring and reviewing SAPs, protocols, CSRs, and regulatory submission documents.
• Hands-on experience with statistical programming environments such as R and/or SAS, including review of analysis code and outputs.
• Proven ability to effectively manage external vendors and CRO partners within a matrixed development environment.
• Experience participating in Health Authority interactions and supporting global submissions strongly preferred.
• Excellent communication, collaboration, and influencing skills with the ability to communicate complex statistical concepts to both technical and non-technical audiences.
• Demonstrated success operating in a fast-paced, highly collaborative biotech environment with evolving priorities.
• Prior people management and team development experience preferred.