Director/Senior Director, Biostatistics

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, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs 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. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

About This Role:

Axsome Therapeutics is seeking a Director/Senior Director, Biostatistics that will play a critical role in the design, analysis, and interpretation of clinical trial data. This position involves collaborating with cross-functional clinical research teams to support the development of new therapies and ensure the integrity and accuracy of statistical analyses.

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.

JOB RESPONSIBILITIES

• Oversee and manage CRO (statistics and data management) activities to ensure timely and quality statistical support to the company’s clinical development efforts.
• Lead or supervise statistical activities in the design, analysis and reporting of all phases of clinical trials.
• Provide statistical guidance and support to project teams.
• Prepare statistical sections of clinical study reports, regulatory submissions, and publications.
• Collaborate with clinical and regulatory teams to ensure study protocols and statistical analysis plans meet regulatory requirements and scientific standards.
• Analyze, interpret, and present statistical results to internal and external stakeholders.
• Ensure the accuracy and integrity of data through rigorous quality control procedures.
• Participate in cross-functional meetings and contribute to strategic planning.
• Ensure all statistical activities comply with regulatory guidelines and company policies.
• Assist in the preparation of regulatory documents, including Investigational New Drug (IND) applications and New Drug Applications (NDAs).

REQUIREMENTS / QUALIFICATIONS 

• Master’s degree