About This RoleAxsome 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, Biostatistics, 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. 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.
