Executive Director, Biostatistics

Cytokinetics•South San Francisco, CA

1d•Hybrid

About The Position

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact. The Executive Director of Biostatistics, reporting to the Vice President of Biometrics, is a senior scientific and strategic leader accountable for setting the vision, strategy, and execution of the Biostatistics function across Cytokinetics’ full R&D portfolio. This role serves as the primary internal and external spokesperson for Biostatistics, ensuring the function is strategically positioned as a critical driver of 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 is accountable for methodological integrity, quantitative innovation, and analytical quality of statistical contributions across all development stages, ensuring that high-quality data and rigorous analyses are translated into clear, actionable insights that inform program and portfolio decisions. As a core member of the development leadership team, the Executive Director actively shapes drug development strategy by embedding robust statistical thinking, quantitative risk assessment, and decision frameworks into study design, endpoint selection, and portfolio prioritization. In close partnership with Clinical Development, Regulatory, Data Sciences, and other R&D functions, this leader ensures that decisions at every stage of development are grounded in sound data, appropriate assumptions, and strong technical and regulatory foundations, enabling confident and timely advancement of programs across the pipeline. With a highly visible and collaborative presence across the organization, this role plays a central part in driving cross-functional alignment, strengthening Cytokinetics’ data-driven culture, and generating compelling scientific evidence to advance the pipeline and deliver meaningful therapies to patients.

Requirements

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

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