Senior Biostatistics Lead, Clinical Trials

Cytokinetics, Inc.; South San Francisco (CA); On-site; USD 198,000 - 231,000; Full time

Benefits offered by this job

Stock options/RSUs

Health, dental, vision insurance

401k with employer match

Paid time off

Learning and wellness stipends

Job summary

Cytokinetics, Inc. is seeking a Senior Biostatistics Manager to guide design and analysis of clinical studies, applying statistical expertise to inform trial strategy and regulatory interactions.

The role emphasizes developing SAPs, analyzing complex data, and contributing to CRFs, while collaborating with cross-functional teams and leveraging ML/AI techniques to enhance insights from biomedical datasets.

Qualifications

• Ph.D./MS in Statistics/Biostatistics with biotech/pharma experience.
• Solid technical foundation in statistics and trial design.
• Proficiency in SAS and/or R; able to translate analyses into actionable insights.
• Experience with high-dimensional or biomarkers and regulatory contexts.
• Strong written and verbal communication for cross-functional audiences.

Responsibilities

• Provide statistical support and strategic input to clinical development plans and target product profiles.
• Draft and review protocols, SAPs, and CRFs to align with trial goals.
• Perform analyses per SAPs, handling novel endpoints or biomarkers.
• Collaborate with study teams to meet deliverables and define processes.
• Summarize findings clearly and communicate implications to stakeholders.
• Contribute to clinical study reports and regulatory submissions.

Skills

SAS proficiency

R proficiency

Statistical analysis

ML/AI familiarity

Cross-functional collaboration

Scientific communication

Education

Ph.D./MS in Statistics/Biostatistics

Tools

SAS

R

ML/AI concepts

Job description

Cytokinetics, Inc. is seeking a Senior Biostatistics Manager to guide design and analysis of clinical studies, applying statistical expertise to inform trial strategy and regulatory interactions.

The role emphasizes developing SAPs, analyzing complex data, and contributing to CRFs, while collaborating with cross-functional teams and leveraging ML/AI techniques to enhance insights from biomedical datasets.