Director/Senior Director, Biostatistics

Role Summary

The Director/Senior Director, Biostatistics provides expertise and guidance in collaboration with cross-functional groups across the organization to establish study design and analyses, contribute to strategy, and institute best practices for planning, execution, interpretation, and regulatory submission of clinical projects and studies. The role provides oversight to ensure high-quality, timely deliverables. It is an individual contributor position reporting to the Head of Biostatistics. Location: New York, NY.

Responsibilities

• Provide strategic input to optimize trial designs in both early phase and/or late phase registrational studies
• Proactively collaborate with clinical trial team to support study conduct
• Collaborate closely with the Medical Affairs and other departments to support evidenced generation and publication
• Provide oversight for external CRO to ensure timely deliverables
• Serve as statistical lead in support of IND/NDA/MAA or other regulatory interactions; provide thorough review for clinical documents, briefing books, and required components of regulatory submissions including appropriate datasets, define files, reviewer's guides, and other relevant documents
• Lead initiatives within Biostatistics function, and contribute to cross-functional process improvement efforts
• Perform QC of statistical deliverables including validation of key results
• Author or oversee the development of statistical analysis plans, statistical sections of protocols, and clinical study reports
• Stay updated with regulatory requirements and advanced statistical
• Conduct ad hoc analyses if needed
• Additional duties and responsibilities as required

Qualifications

• Profound understanding of advanced clinical trial design and statistical analysis methodologies
• Good understanding of the big picture of an overall development program
• Capable of thinking strategically
• Excellent communication and interpersonal skills
• Ability to lead project teams, as well as work in a cross-functional team
• Good leadership skills
• Strong ability to quickly capture key information from medical journal articles
• Understand regulatory requirements and good clinical practice guidelines
• Ability to multitask and prioritize work
• Good statistical programming skills using SAS and other statistical software

Skills

• Advanced statistical analysis and trial design
• Cross-functional collaboration and project leadership
• Regulatory knowledge and good clinical practice guidelines
• Strong written and verbal communication
• Statistical programming in SAS and other software

Education

• Ph.D. or M.S., Biostatistics or equivalent with at least 8 years of pharmaceutical, biotechnology, or equivalent experience.