Senior Biostatistician

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.

About This Role:

Axsome Therapeutics is seeking a Senior Biostatistician to support the Medical Affairs Group. The Senior Biostatistician will primarily support data generation efforts within Medical Affairs, including secondary analysis of clinical trials, Health Economics and Outcomes Research (HEOR), and Real-World Evidence (RWE) studies. Additionally, this role will provide statistical support to Clinical Development on late stage (Phase 2/3) clinical trials as needed. The Senior Biostatistician will be responsible for developing and executing sound scientific and statistical analysis, interpretation, design, and communication of clinical/HEOR/RWE data to support research, development and marketed product needs at Axsome Therapeutics, Inc. This position reports to the Director, Biostatistics.

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

• Work closely with the Director, Biostatistics to provide statistical support to Medical Affairs through data generation efforts specific to secondary analysis of clinical trials, HEOR, and RWE activities, and provide statistical support and strategic input to Clinical Development for late stage (Phase 2/3) clinical trials
• Oversee statistical aspects of assigned studies/projects to ensure that scientific, regulatory, and quality requirements are met and that plans are aligned with development and commercialization goals
• Collaborate with cross-functional teams composed of internal functional leads and/or external experts/vendors to provide hands-on data generation support by developing statical analysis plans, programming statistical analyses, and interpreting statistical results
• Provide statistical input to study reports, value/reimbursement dossier, publications, and other internal or external data requests
• Collaborate with Clinical Development, Medical Writing, and Regulatory Affairs project team members and consultants to development clinical study protocols and clinical study reports
• Prepare, review and/or approve analysis, case report forms, database specifications, validation plans, TFLs, reporting and analyses datasets specifications, and supporting documentation for clinical trials or observational studies
• Review and provide feedback on analytical work conducted by colleagues, external collaborators, or third-party service providers related to HEOR, RWE and other functions as applicable
• Work across a variety of projects/programs and meets timelines with a high degree of accuracy and efficiency
• Communicate statistical methods and results to internal and external stakeholders
• Contribute to the development and maintenance of Biostatistics-related SOPs, work practice documents, technical standards, and specification documents
• Research, identify, and implement new and innovative statistical methods for the analysis of clinical trial and observational data
• Develop new or leverage existing statistical methodologies to convert data into information to enable decision making

REQUIREMENTS / QUALIFICATIONS 

• PhD Degree in with 1-2 years/ MS with 4 years/BS with 8 years in pharmaceutical statistics (preferably industry experience in clinical trials)
• Degree in Statistics, Biostatistics, or a related discipline
• Understanding of fundamental principles, best statistical practices, and industry guidelines applicable to clinical studies, HEOR, RWE
• Advanced knowledge of working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets
• Advanced programming skills in R and Quarto/Markdown; working knowledge of Git; fluency in SAS a plus
• Ability to travel up to 10%
• 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

• Hands-on experience in extracting, organizing, and analyzing data from clinical trial databases, claims databases, electronic medical records, registries, or other epidemiological data sources
• Experience with study designs, power/sample size computations, longitudinal data analysis, survival analysis, cost-effectiveness analysis, statistical modeling, and simulation
• Knowledge of the drug development process, from early to late stage; experience in CNS preferred
• Vendor oversight experience
• Ability to manage multiple tasks with competing timelines
• Excellent communication, collaboration, problem-solving, analytical thinking and computer skills
• Ability to explain statistical concepts to non-statisticians
• Strong organizational skills and proven ability to effectively lead a project to successful completion
• Solution oriented, attention to detail, interest and ability to perform in a high-demand and dynamic working environment
• Remain up to date on the latest developments in data manipulation and statistical analysis

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.