Associate Director/Director, Biostatistics

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 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. 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 Associate Director/Director, Biostatistics to provide statistical support for multiple neurology compounds across all phases of development. Reporting to the Senior Director of Biostatistics and Programming. the Associate Director/Director, 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 Associate Director/Director, 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.

Job Responsibilities and Duties

include, but are not limited to, the following:

• Lead and manage all statistical activities within clinical studies (i.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

• 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 degree within the pharmaceutical, biotechnology, CRO, or related life sciences industry
• Director: 10+ years of biostatistics experience with a Ph.D. or 12+ years with a Master's degree within the pharmaceutical, biotechnology, CRO, or related life sciences industry.
• Experience with clinical trial design, analysis and reporting
• Experience in Phase III and III pivotal clinical development studies
• Strong statistical programming skills in SAS
• Ability to work on-site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

Experience, Knowledge and Skills

• Modeling and simulation skills are preferred
• Strong ability to manage time and resources, ensuring the successful achievement of pre-determined deadlines
• Flexibility in approach, while ensuring the delivery of high-quality work in a dynamic work environment, with competing priorities
• Experience marketing application submissions to regulatory authorities is strongly preferred
• Experience overseeing and managing CRO's statistical analysis of assigned clinical trials
• Excellent communication and presentation skills (written and verbal)
• Demonstrated ability to effectively interact with internal team members and external parties that do not possess the knowledge and background to readily understand the application of statistics to drug development and study outcomes

Salary & Benefits

The anticipated salary range for this role is $185,000-$230,000. 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.