Axsome Therapeutics

Manager/Senior Manager, Statistical Programming

New York, NY · Senior

Sponsorship not specified$130k-$155kDetected 57 days ago

PythonData AnalysisStatisticsSAPRecruitingClinical TrialsFDA RegulatorySASResearchCommunicationCollaborationOrganizational SkillsBiostatistics

About the role

As part of the submission team, this role will help provide rapid responses to inquiries from the FDA and other regulatory authorities.
This role reports to the Senior 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.

Axsome Therapeutics is seeking a Manager/Senior Manager, Statistical Programming to provide programming support for multiple neurology compounds across all phases of development.
This position will also manage Contract Research Organizations (CROs) providing programming support, and eSubmission package planning, execution, and quality checks of package components for data submission to global regulatory authorities.
Develop, validate, and execute SAS programs and macros to generate SDTM and ADaM datasets and presentation-ready TFL outputs, as defined in the SAP, for the CSR and for regulatory submissions
Manage CRO partners to ensure the delivery of datasets and TFL outputs according to project timelines
2+ years of SDTM and ADaM lead experience
Demonstrated experience developing and validating eSubmission data package components for regulatory submissions, amendments, and supplements
Possesses strong organizational skills, with an ability to manage time and resources to ensure the successful achievement of pre-determined deadlines
Ability to oversee and manage a CRO's CDISC and ADaM dataset-related activities and Table/Figure/Listing programming activities for assigned clinical trials

Bachelor's degree (BA or BS) in Computer Science, Mathematics, Statistics, Engineering, Life Science, or related discipline
Must have excellent communication and presentation skills

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.
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.