Executive Director, Biostatistics jobs in United States
cer-icon
Apply on Employer Site
company-logo

Cytokinetics · 8 hours ago

Executive Director, Biostatistics

Cytokinetics is a specialty cardiovascular biopharmaceutical company focused on advancing new medicines for patients with cardiac muscle dysfunction. The Executive Director of Biostatistics will lead the Biostatistics function, ensuring strategic alignment and data-driven decision-making throughout the R&D portfolio.

BiopharmaBiotechnologyHealth Care

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

Qualification

Ph.D. in StatisticsStatistical methodology expertiseStatistical analysis softwareRegulatory guidelines knowledgeExecutive communication skillsLeadership skillsOrganizational skillsChange managementTeam collaborationProblem-solving skills

Required

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

Company

Cytokinetics

twittertwittertwitter
company-logo
Cytokinetics is a biopharmaceutical company developing therapies for debilitating diseases.

Funding

Current Stage
Public Company
Total Funding
$2.41B
Key Investors
Royalty PharmaDeerfieldVulcan
2025-09-16Post Ipo Debt· $650M
2024-05-22Post Ipo Equity· $550M
2024-05-22Post Ipo Debt· $50M

Leadership Team

leader-logo
Robert Blum
President & CEO
linkedin
leader-logo
Sung Lee
EVP & CFO
linkedin
Company data provided by crunchbase