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 that enable meaningful advancements in patient outcomes. Our industry-leading 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, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States.

Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. com and follow us on LinkedIn and X.

About This Role

Axsome Therapeutics is seeking a Senior Manager, Biostatistics to provide statistical support for multiple neurology compounds across all phases of development. Reporting to the Senior Director, Biostatistics, the Senior Manager, Biostatistics will serve as lead statistician on assigned clinical trials, and in collaboration with project team members provide statistical input on trial design, protocol development, and manage creation of Statistical Analysis Plans (SAPs). Additionally, the Senior Manager, Biostatistics will manage Contract Resource Organization (CRO) partners in the creation of statistical outputs, with hands-on quality checks of the outputs.

This role will contribute to Clinical Study Report (CSR) writing, and regulatory submission documents. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.

Responsibilities

e. contributing to study design and selection of appropriate data analysis methods, sample size estimation) Partner with other functional members, external consultants, key opinion leaders, medical advisors and CRO’s/contractors, to ensure the quality and integrity of the data is maintained while identifying, and minimizing where possible, risks to the studies/projects Collaborate with external CRO partners, manage creation of study SAPs based on regulatory guidance and sound statistical methodology, as well as creation of Table, Figure, and Listing shells, as per study timelines Review Case Report Forms, and other supportive clinical trial documentation such as the Protocol Deviation Plan, and Data Management Plan. Support clinical data reviews for data quality, outlier identification, trend analysis, and potential impact on trial results, using SAS and data visualization software, during trial conduct Perform hands-on quality checks of CRO deliverables using SAS and/or R.

Contribute to CSR writing, including interpretation of trial results, and quality checks of data presentations. Contribute to regulatory submission documents, including IND applications, FDA meeting briefing materials, and NDA submission documents, including eCRT packages. Conduct ad hoc analyses using SAS and/or R in support of assigned projects.

Contributes to development of Standard Operating Procedures (SOPs), Work Instructions, and templates within function. Ensure knowledge transfer during and at the completion of the studies/projects. Stay up to date with changes in the field of statistics.

Implements new ideas and advanced processes, where applicable.

Requirements

Qualifications

D. D.