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Director/Senior Director – Biostatistics
| Company | Syndax |
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| Location | New York, NY, USA |
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| Salary | $225000 – $305000 |
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| Type | Full-Time |
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| Degrees | Master’s, PhD |
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| Experience Level | Senior, Expert or higher |
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Requirements
- Ph.D. or M.S., Biostatistics or equivalent with at least 8 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.
- Good statistical programming skills using SAS and other statistical software.
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; 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 methodology and provide guidance to junior statisticians
- Conduct ad hoc analyses if needed
- Additional duties and responsibilities as required
Preferred Qualifications
- 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
