Senior Director, Biostatistics & Clinical Trials Strategy

Cytokinetics; San Francisco (CA); On-site; USD 286,000 - 334,000; Full time

Benefits offered by this job

Stock options

401k with match

Health insurance

Dental insurance

Vision insurance

Life & disability insurance

Wellness stipend

Paid time off

Job summary

Cytokinetics is seeking an experienced biostatistics leader to provide strategic input and direct management of biostatistics staff across late-phase clinical trials and real-world studies. The role emphasizes development of statistical strategy, design and analyses for multiple compounds with regulatory and payer evidence generation focus.

The position requires an MS/MA or PhD in statistics/biostatistics with 12+ years of clinical trials experience, and strong leadership, vendor management, and

Qualifications

• MS/MA or PhD in Statistics/Biostatistics or related discipline with minimum 12 years of clinical trials experience.
• Experience leading late-phase and post-marketing studies and providing strategic input.
• Knowledgeable about FDA/EMA/ICH guidelines and CDISC standards.

Responsibilities

• Provide strategic input on Cytokinetics development programs.
• Lead statistical design, conduct and analysis of late-phase trials and real-world studies.
• Oversee SOPs, budgets, timelines and CRO/vendor relationships.
• Direct supervision of biostatisticians and mentoring of staff.
• Collaborate with clinical research and medical affairs to generate evidence for regulators.

Skills

Leadership

Biostatistics leadership

Statistical design

Clinical trials

Vendor management

Education

MS/MA or PhD in Statistics/Biostatistics

Job description

Cytokinetics is seeking an experienced biostatistics leader to provide strategic input and direct management of biostatistics staff across late-phase clinical trials and real-world studies. The role emphasizes development of statistical strategy, design and analyses for multiple compounds with regulatory and payer evidence generation focus.

The position requires an MS/MA or PhD in statistics/biostatistics with 12+ years of clinical trials experience, and strong leadership, vendor management, and