Senior Biostatistics Lead, Clinical ML Analytics

Cytokinetics, Inc.; United States; On-site; USD 242,100 - 282,450; Full time

Benefits offered by this job

Stock options

Restricted stock units

Health, dental, vision, life and long‑

401k with employer match

Learning and wellness stipends

Paid time off

Job summary

Cytokinetics, Inc. is seeking a lead statistician to drive statistical leadership for clinical development and study designs. You will serve as SME in Biostatistics, guiding analyses across Phase 1‑4 trials and collaborating with multiple functions to ensure rigorous methods and regulatory readiness.

You will combine trial expertise with machine learning to extract insights from clinical data, enabling informed development decisions and interactions with regulators and payers.

Qualifications

• Ph.D. or M.S. in Statistics/Biostatistics with 8+ years (Ph.D.) and 12+ years (M.S.) biotech/pharma experience.
• Hands‑on design and analysis of clinical trials and applying machine learning tools is a must.
• Ability to work independently and within a team.
• Solid knowledge in ICH and regulatory requirements related to biostatistical activities and clinical trials.
• Excellent verbal and written communication skills are required.
• Great interpersonal and collaborative skills are essential.
• Demonstrated interest and ability to lead projects and mentor junior colleagues.

Responsibilities

• Provide statistical leadership for clinical development plans and trials, contributing to governance reviews.
• Represent Biostatistics on cross-functional teams and act as lead statistician on studies.
• Collaborate on study design, SAP, and analysis specifications with other functions.
• Guide DMC planning and coordination with independent statistical data analysis centers.
• Support data management, clinical operations, and database development activities.
• Ensure appropriate programming and outputs for datasets and analyses per protocols.
• Contribute to regulatory submissions and health authority communications.
• Support primary and secondary publications and data interpretation.
• Address methodological challenges and explore multimodal data (biomarkers, imaging, real‑world data).
• Drive department initiatives, best practices, and AI/ML alignment across Cytokinetics.

Skills

Statistics expertise

Biostatistics

Machine learning

Leadership

Communication

Education

Ph.D. in Statistics/Biostatistics

M.S. in Statistics/Biostatistics

Job description

Cytokinetics, Inc. is seeking a lead statistician to drive statistical leadership for clinical development and study designs. You will serve as SME in Biostatistics, guiding analyses across Phase 1‑4 trials and collaborating with multiple functions to ensure rigorous methods and regulatory readiness.

You will combine trial expertise with machine learning to extract insights from clinical data, enabling informed development decisions and interactions with regulators and payers.