Senior Manager, Biostatistics

About the Company

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action.

Responsibilities

• Lead and manage all statistical activities within clinical studies, including study design and sample size estimation
• Partner with functional members, external consultants, and CROs to ensure data quality and integrity
• Collaborate with external CRO partners to manage the creation of study SAPs and Table, Figure, and Listing shells
• Review Case Report Forms and other clinical trial documentation such as Protocol Deviation and Data Management Plans
• Support clinical data reviews for quality, outlier identification, and trend analysis using SAS and data visualization software
• Perform hands-on quality checks of CRO deliverables using SAS and/or R
• Contribute to CSR writing and regulatory submission documents including IND, FDA briefing materials, and NDA submissions
• Conduct ad hoc analyses using SAS and/or R in support of assigned projects

Requirements

• Master’s degree or Ph.D. in Biostatistics, Statistics, Mathematics, or Medical Statistics
• 4+ years of statistics experience with a Ph.D. or 7+ years with a Master’s degree in the pharmaceutical, biotech, or medical sector
• Experience in Phase III and III pivotal clinical development studies
• Strong statistical programming skills in SAS
• Ability to work on-site in New York City at least three days per week

Preferred Qualifications

• Modeling and simulation skills
• Experience marketing application submissions to regulatory authorities
• Experience overseeing and managing CRO statistical analysis