Senior Manager, Biostatistics

Axsome Therapeutics•New York, NY

5d•$140,500 - $170,000•Onsite

About The Position

Axsome Therapeutics is seeking a Senior Manager, Biostatistics to provide statistical support for multiple neurology compounds across all phases of development. Reporting to the Senior Director, Biostatistics, the Senior Manager, 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 Senior Manager, 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.

Requirements

Master’s degree or Ph.D. degree in Biostatistics, Statistics, Mathematics, or Medical Statistics, or a related discipline
At least 4 years of statistics experience with a Ph.D. degree or 7+ years with a Master’s degree within the pharmaceutical industry (including contract research organizations (CROs)), biotechnology or medical sector, including 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

Nice To Haves

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

Responsibilities

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.