Syndax Pharmaceuticals is looking to solve the business problem of realizing a future in which people with cancer live longer and better than ever before by developing an innovative pipeline of cancer therapies.
Requirements
- Profound understanding of advanced clinical trial design and statistical analysis methodologies
- Good understanding of the big picture of an overall development program
- Good statistical programming skills using SAS and other statistical software
- Understand regulatory requirements and good clinical practice guidelines
- Ph.D. or M.S., Biostatistics or equivalent with at least 8 years of pharmaceutical, biotechnology, or equivalent experience
- Capable of thinking strategically
- Strong ability to quickly capture key information from medical journal articles
Responsibilities
- Serve as an influential statistical lead for clinical programs
- 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
- Provide oversight for external CRO to ensure timely deliverables
- Serve as statistical lead in support of IND/NDA/MAA or other regulatory submissions
- Author or oversee the development of statistical analysis plans, statistical sections of protocols, and clinical study reports
- Perform QC of statistical deliverables including validation of key results
Other
- Excellent communication and interpersonal skills
- Ability to lead project teams, as well as work in a cross-functional team
- Good leadership skills
- Ability to multitask and prioritize work
- Ph.D. or M.S., Biostatistics or equivalent with at least 8 years of pharmaceutical, biotechnology, or equivalent experience
