Director, Biostatistics - Onsite NYC

Axsome Therapeutics, Inc.; New York (NY); On-site; USD 185,000 - 230,000; Full time

Job summary

Axsome Therapeutics, Inc. in New York City seeks an Associate Director/Director, Biostatistics to provide statistical leadership across multiple neurology programs, guiding trial design, SAPs, and CSR writing.

Reporting to the Senior Director of Biostatistics and Programming, you will manage CRO partners, oversee data quality, and contribute to regulatory submissions, including INDs and NDAs. This on-site role requires in-office presence three days per week.

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; Director: 10+ years with a Ph.D. or 12+ years with a Master’s.
• Experience with clinical trial design, analysis and reporting; Phase III experience.
• Strong SAS programming skills; ability to work on-site three days/week.

Responsibilities

• Lead and manage all statistical activities within clinical studies, including design and sample size estimation.
• Collaborate with CROs and internal teams to ensure data quality and integrity.
• Develop SAPs and contribute to CSR writing and regulatory submissions.
• Oversee creation of tables, figures, and listings per study timelines.
• Support regulatory submissions and documentation (IND/NDA).
• Stay updated with statistical methodologies and SOP development.

Skills

Statistical modeling

Regulatory submissions experience

Project management

Communication skills

Education

Ph.D. or Master’s in Biostatistics/Statistics/Medical Statistics

Tools

SAS

R

Job description

Axsome Therapeutics, Inc. in New York City seeks an Associate Director/Director, Biostatistics to provide statistical leadership across multiple neurology programs, guiding trial design, SAPs, and CSR writing.

Reporting to the Senior Director of Biostatistics and Programming, you will manage CRO partners, oversee data quality, and contribute to regulatory submissions, including INDs and NDAs. This on-site role requires in-office presence three days per week.