Senior Director, Biostatistics & Clinical Strategy

Cytokinetics, Inc.; South San Francisco (CA); Híbrido; USD 286 000 - 334 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Equity in stock options

Comprehensive health coverage

Dental coverage

Vision coverage

Life and disability insurance

401k retirement benefits

Learning and wellness stipends

Paid time off

Resumo da oferta

Cytokinetics, Inc. in South San Francisco, CA, is seeking a leader to guide the biostatistics function across late-phase and post-marketing studies.

You will set strategy, oversee trial design/analysis, and mentor statisticians while partnering with clinical research and medical affairs to support regulators, providers and payers. The role emphasizes strong regulatory knowledge, collaboration, and vendor oversight to deliver high-quality statistical work on multiple compounds under tight

Qualificações

• MS/MA or PhD in Statistics/Biostatistics with 12+ years of clinical trials experience.
• Experience leading Phase 3/4 trials and cardiovascular/neuromuscular studies.
• Strong regulatory knowledge and CDISC standards.
• Ability to manage budgets and CROs.

Responsabilidades

• Provide strategic input on Cytokinetics development programs.
• Provide input on clinical development plans, including post-marketing evidence generation and safety signal seeking.
• Develop and implement department standards and practices and oversee process improvements.
• Provide technical oversight of statistical design, conduct, and analysis of late-phase trials and real-world data studies.
• Write and review protocols and statistical analysis plans and CRFs.
• Evaluate and manage CROs and vendors, including scopes of work, timelines and budgets.
• Build strong relationships within biostatistics and with other functions.

Conhecimentos

Leadership

People management

Biostatistics

Clinical trials

CDISC

Regulatory guidelines

Vendor management

Communication

Project management

FDA/EU experience

Formação académica

Statistics PhD

Descrição da oferta de emprego

Cytokinetics, Inc. in South San Francisco, CA, is seeking a leader to guide the biostatistics function across late-phase and post-marketing studies.

You will set strategy, oversee trial design/analysis, and mentor statisticians while partnering with clinical research and medical affairs to support regulators, providers and payers. The role emphasizes strong regulatory knowledge, collaboration, and vendor oversight to deliver high-quality statistical work on multiple compounds under tight