Senior Biostatistician

COMPANY DESCRIPTION

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

JOB SUMMARY

Axsome Therapeutics is seeking a Senior Biostatistician 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 or Ph.D. in Biostatistics, Statistics, or a related field.
• Minimum of 3-5 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. We are unable to consider candidates who are looking for fully remote roles

Experience and Knowledge

• Strong analytical and problem-solving skills.
• Leadership and CRO management skills.
• Attention to detail and commitment to quality.
• Ability to manage multiple projects and meet deadlines.
• Knowledge of Good Clinical Practice (GCP) and regulatory guidelines.

Salary and Benefits:

The anticipated salary range for this role is $125,000 - $140,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. 

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.