Director, Biostatistics

Role Summary

Director, Biostatistics at Syndax Pharmaceuticals. The role provides expertise and guidance in cross-functional collaboration to establish study design and analyses, and to oversee planning, execution, interpretation, and regulatory submission of clinical projects. This individual contributor role reports to the Head of Biostatistics.

Responsibilities

• Provide strategic input to optimize trial designs in both early phase and late phase registrational studies
• Proactively collaborate with clinical trial team to support study conduct
• Collaborate with Medical Affairs and other departments to support evidence generation and publication
• Provide oversight into external CRO to ensure timely deliverables
• Serve as statistical lead in support of IND/NDA/MAA or other regulatory interactions; review clinical documents, briefing books, and components of regulatory submissions including datasets, define files, reviewer's guides, and other relevant documents
• Lead initiatives within Biostatistics and contribute to cross-functional process improvements
• 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 methodology
• Conduct ad hoc analyses if needed
• Additional duties and responsibilities as required

Qualifications

• Ph.D. or M.S., Biostatistics or equivalent with at least 5 years of pharmaceutical, biotechnology, or equivalent experience
• 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

Location

New York, NY