Axsome Therapeutics

Senior Manager, Biostatistics

New York, NY · Senior

Sponsorship not specified$140k-$170kDetected 61 days ago

Data AnalysisData VisualizationStatisticsRecruitingClinical TrialsFDA RegulatorySASResearchExperimental DesignCommunicationCollaborationBiostatistics

About the role

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:

Axsome Therapeutics is seeking a Senior Manager, Biostatistics to provide statistical support for multiple neurology compounds across all phases of development.
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.
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)
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
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
Conduct ad hoc analyses using SAS and/or R in support of assigned projects.
Perform hands-on quality checks of CRO deliverables using SAS and/or R.
Contribute to regulatory submission documents, including IND applications, FDA meeting briefing materials, and NDA submission documents, including eCRT packages.
Implements new ideas and advanced processes, where applicable.
Strong ability to manage time and resources, ensuring the successful achievement of pre-determined deadlines

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

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.

gard 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, genet

This listing is sourced directly from Axsome Therapeutics's careers page and normalized into a canonical job model.