Senior Director, Biostatistics — Cardiovascular Trials

Cytokinetics; South San Francisco (CA); Hybrid; USD 286,000 - 334,000; Full time

Benefits offered by this job

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Job summary

Cytokinetics in South San Francisco, CA, seeks a senior leader to head the biostatistics function, guiding strategy, design, and analyses for multiple cardiovascular-focused trials, including late-phase and post-marketing studies.

You will recruit and mentor statisticians, set department standards, oversee external vendors, and ensure rigorous statistical methods while collaborating with regulatory and clinical teams.

Qualifications

• MS/MA or PhD in Statistics/Biostatistics or related discipline and a minimum of 12 years of clinical trials experience.
• Experience leading phase 3 and phase 4 studies.
• Knowledge of FDA/EMA/ICH guidelines for drug development.

Responsibilities

• Provide strategic input on Cytokinetics development programs.
• Provide vision and direction for department standards and practices and oversight of process improvement initiatives.
• Technical oversight of the statistical design, conduct, and analysis of late phase trials and real-world data studies including safety evaluation.
• Write and review protocols and statistical analysis plans.
• Evaluate and manage CROs and vendors including scope-of-work, timelines, and budgets.
• Lead and mentor biostatisticians and foster cross-functional collaboration.

Skills

People management

Communication skills

Statistical design

Clinical trial knowledge

FDA/EU/ICH guidelines

Cross-functional collaboration

Vendor management

Problem solving

Education

MS/MA in Statistics/Biostatistics or PhD

Tools

CDISC standards

Job description

Cytokinetics in South San Francisco, CA, seeks a senior leader to head the biostatistics function, guiding strategy, design, and analyses for multiple cardiovascular-focused trials, including late-phase and post-marketing studies.

You will recruit and mentor statisticians, set department standards, oversee external vendors, and ensure rigorous statistical methods while collaborating with regulatory and clinical teams.