Director, BiostatisticsThe 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-functional process improvement efforts
- Additional duties and responsibilities as required
Desired Experience/Education and Personal Attributes:- 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: Syndax's corporate office is in New York, NY.
Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $235,000 -$260,000.
#LI- Remote
