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About the Role

Axsome Therapeutics is seeking an Associate Director/Director, Biostatistics to provide statistical support for multiple neurology compounds across all phases of development. This role will serve as lead statistician on assigned clinical trials, contributing to trial design, protocol development, and managing the creation of Statistical Analysis Plans (SAPs). The position also involves managing Contract Resource Organization (CRO) partners, performing quality checks, contributing to Clinical Study Reports (CSRs), and regulatory submission documents.

Responsibilities

Lead and manage all statistical activities within clinical studies, including study design, data analysis methods, and sample size estimation.
Partner with functional members, external consultants, key opinion leaders, medical advisors, and CROs/contractors to ensure data quality and integrity, while identifying and minimizing study/project risks.
Collaborate with external CRO partners to manage the creation of study SAPs based on regulatory guidance and statistical methodology, as well as Table, Figure, and Listing shells.
Review Case Report Forms and other 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.
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.
Contribute to the development of Standard Operating Procedures (SOPs), Work Instructions, and templates within the function.
Ensure knowledge transfer during and at the completion of studies/projects.
Stay up to date with changes in the field of statistics and implement new ideas and advanced processes where applicable.

Requirements

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 II and III pivotal clinical development studies.
Strong statistical programming skills in SAS.
Ability to work on-site Monday, Tuesday & Thursday.
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 CROs' 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.

Skills

SAS
R
Data visualization software
Statistical programming

Location

New York City

Work Type

On-site (at least three days per week)

Experience Level

Associate Director
Director

Education Level

Ph.D. or Master's degree in Biostatistics, Statistics, Mathematics, Medical Statistics, or a related quantitative discipline

Salary/Compensations

$185,000-$230,000

Benefits

Annual bonus
Significant equity
Generous benefits package

About the Company

Axsome Therapeutics is a biopharmaceutical company focused on treating 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.

Equal Opportunity

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.