Associate Director/Director, Biostatistics

The role

The Associate Director/Director, Biostatistics will provide statistical support for multiple neurology compounds across all phases of development. This person will serve as lead statistician on assigned clinical trials and manage CRO partners.

What you will do

• Lead and manage all statistical activities within clinical studies
• Partner with functional members, external consultants, and CROs to ensure data quality
• Collaborate with external CRO partners to manage creation of study SAPs and shells
• Review Case Report Forms and other clinical trial documentation
• Support clinical data reviews using SAS and data visualization software
• Perform hands-on quality checks of CRO deliverables using SAS and/or R
• Contribute to CSR writing and quality checks of data presentations
• Contribute to regulatory submission documents including IND and NDA submissions
• Conduct ad hoc analyses using SAS and/or R
• Contribute to development of SOPs, Work Instructions, and templates

Required qualifications

• Ph.D. or Master's degree in Biostatistics, Statistics, Mathematics, Medical Statistics, or a related quantitative discipline
• Associate Director: 8+ years of biostatistics experience with a Ph.D. or 10+ years with a Master's degree within the pharmaceutical, biotechnology, CRO, or related life sciences industry
• Director: 10+ years of biostatistics experience with a Ph.D. or 12+ years with a Master's degree within the pharmaceutical, biotechnology, CRO, or related life sciences industry
• Experience with clinical trial design, analysis and reporting
• Experience in Phase III and III pivotal clinical development studies
• Strong statistical programming skills in SAS
• Ability to work on-site Monday, Tuesday & Thursday

Nice to have

• Modeling and simulation skills
• Experience marketing application submissions to regulatory authorities

Benefits

• Annual bonus
• Significant equity
• Generous benefits package

About the company

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. Their neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine.