Director, Biostatistics

Syndax Pharmaceuticals•New York, NY

5d•$235,000 - $260,000•Remote

About The Position

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.

Requirements

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

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