Executive Director, Biostatistics

Role Summary

Executive Director, Biostatistics is a senior scientific and strategic leader responsible for setting the vision, strategy, and execution of the Biostatistics function across Cytokinetics’ full R&D portfolio. The role serves as the primary internal and external spokesperson for Biostatistics, ensuring the function drives data‑driven decision making, evidence generation, regulatory success, and long‑term value creation. The Executive Director provides comprehensive leadership of the Biostatistics organization, including talent strategy, organizational design, succession planning, career development, and performance management, while fostering a culture of scientific rigor, transparency, accountability, and operational excellence. The role shapes drug development strategy by embedding robust statistical thinking, quantitative risk assessment, and decision frameworks into study design, endpoint selection, and portfolio prioritization, working in close partnership with Clinical Development, Regulatory, Data Sciences, and other R&D functions to enable confident and timely advancement of programs.

Responsibilities

• Define and execute the strategic vision for the Biostatistics function across the enterprise
• Lead, develop, and inspire a high-performance biostatistics organization, including talent development, succession planning, and performance management
• Provide enterprise leadership in statistical methodology, quantitative innovation, and scientific rigor across all programs and therapeutic areas
• Embed data-driven decision frameworks into clinical development, portfolio strategy, and governance processes
• Lead statistical strategy for clinical trial design, analysis, and interpretation across all phases of development
• Ensure biostatistics input and accountability for major documents, including clinical development plans, protocols, clinical study reports, and regulatory submission documents and summaries of safety and efficacy
• Provide senior leadership in regulatory interactions with FDA, EMA, and other global health authorities
• Guide the use of epidemiologic, observational, and real-world data methods to strengthen development and submission evidence
• Oversee quantitative methods and analytics platforms with a focus on efficiency, scalability, and innovation
• Serve as a key leader on the Biometrics Leadership Team, shaping functional strategy and driving execution
• Lead sponsor–CRO relationships, vendor partnerships, and escalation management
• Establish and govern SOPs, standards, policies, and operating models that ensure quality, compliance, and inspection readiness
• Represent Cytokinetics externally through scientific leadership in industry, academic, and regulatory forums

Qualifications

• Ph.D. in Statistics or Biostatistics with at least 15 years of biotech/pharmaceutical industry experience
• Strong expertise in statistical methodology, including best practices and new industry trends
• Demonstrated proficiency in at least one statistical analysis software
• Expert knowledge of ICH and other relevant regulatory development guidelines
• Ability to explain complex statistical concepts and engage in scientific discourse
• Outstanding executive communication and influence skills
• Proven leadership skills and ability to work effectively in a team environment
• Demonstrated success in leading high-performance, cross-functional teams
• Excellent organizational and problem-solving skills
• Proven ability to drive organizational change, alignment, and execution