Syndax Pharmaceuticals is looking for a Director, Biostatistics to provide expertise and guidance in establishing study design and analyses, strategy, and best practices for clinical projects and studies, ensuring high quality and timely deliverables for their innovative pipeline of cancer therapies.
Requirements
- Profound understanding of advanced clinical trial design and statistical analysis methodologies
- Good statistical programming skills using SAS and other statistical software
- Understand regulatory requirements and good clinical practice guidelines
Responsibilities
- Provide strategic input to optimize trial designs in both early phase and or late phase registrational studies
- 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
- Stay updated with regulatory requirements and advanced statistical methodology
- Conduct ad hoc analyses if needed
Other
- This position is an individual contributor and reports to the Head of Biostatistics.
- Ph.D. or M.S., Biostatistics or equivalent with at least 5 years of pharmaceutical, biotechnology, or equivalent experience.
- 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
- Ability to multitask and prioritize work
- Syndax’s corporate office is in New York, NY.
- The anticipated annualized salary range for this role is $230,000 - $260,000
