Support biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies
Collaborate with cross-functional partners to meet clinical development project deliverables and timelines
Provide statistical consultation on clinical development plans, clinical trial design and clinical study endpoints
Calculate sample size, author statistical analysis plans and provide biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory filings
Contribute to short
and long-range Biostatistics strategies, plans and infrastructure development that transcend multiple areas and teams across Biostatistics

6+ Years of relevant experience with BS/BA in Biostatistics, Statistics, Mathematics, or a related quantitative discipline OR MS in Biostatistics, Statistics, Mathematics, or a related quantitative discipline with 4+ years of relevant experience
PhD in Biostatistics, Statistics, Mathematics, or a related quantitative discipline with 2+ years of relevant experience preferred
Demonstrated ability to be a fast learner
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed
Knowledge of biomedical statistical analysis, best practices and tools
Understanding of drug development phases and associated clinical trials across phases
Strong communication and organizational skills
Experience developing software and other tools to support statistical analysis of biomedical or related data
Strong proficiencies in software and other tools typically used by Biostatistics.

company-sponsored medical, dental, vision, and life insurance plans*
discretionary annual bonus
discretionary stock-based long-term incentives (eligibility may vary based on role)
paid time off

Manager, Biostatistics

Key skills