Director, Biostatistics

Axsome Therapeutics • New York, NY

134d • $200,000 - $240,000

About The Position

Axsome Therapeutics is seeking a 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.

Requirements

• Master's degree with at least 12 years of experience or PhD with at least 8 years of experience in Biostatistics within the pharmaceutical or biotechnology industry.
• Proficiency in statistical software (e.g., SAS, R) and data management tools.
• Strong understanding of clinical trial design, statistical methodologies, and regulatory requirements.
• Excellent communication and presentation skills.
• Ability to work collaboratively in a team environment.
• Ability to work on-site Monday, Tuesday, and Thursday.

Nice To Haves

• Strategic Planning & Program Leadership experience.
• Proven experience in designing and implementing statistical strategies that support long-term clinical and regulatory objectives.
• Ability to anticipate and address statistical challenges in early and late-phase development, including adaptive designs and innovative methodologies.
• Prior experience as a strategic partner in decision-making processes, including go/no-go decisions, dose selection, and portfolio prioritization.
• Expertise in designing complex clinical trials, including pivotal studies, with a focus on statistical rigor, efficiency, and regulatory acceptability.
• Direct experience in preparing statistical content for regulatory submissions (e.g., INDs, NDAs, MAAs) and responding to regulatory queries.
• Participation in regulatory meetings (e.g., FDA, EMA) to represent statistical strategy and defend study designs and analyses.

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).

Benefits

• Competitive employment package including an annual bonus.
• Significant equity.
• Generous benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Master's degree
• Number of Employees: 501-1,000 employees