Director, Biostatistics

Syndax Pharmaceuticals is looking for a

Director, Biostatistics

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role

This role provides expertise and guidance in collaboration with cross-functional groups broadly across the organization in establishing study design and analyses in addition to strategy, and institutes best practices with regards to planning, execution, interpretation and regulatory submission of clinical projects and studies. This role also provides oversight and guidance to ensure high quality and timely deliverables. This person will have strong technical expertise, will be a collaborative team player and proactive problem solver.

Key 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
• Provide oversight into external CRO to ensure timely deliverables
• Serve as statistical lead in support of IND/NDA/MAA or other regulatory interactions; provide thorough reviews for clinical documents, briefing books, and required components of regulatory submissions including appropriate datasets, define files, reviewer's guides, and other relevant documents
• 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
• Collaborate closely with the Medical Affairs and other departments to support evidence generation and publication
• Stay updated with regulatory requirements and advanced statistical methodology
• Conduct ad hoc analyses if needed.
• Lead initiatives within Biostatistics function, and contribute to cross-functiona