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Manager/Senior Manager, Statistical Programming at Axsome Therapeutics - ApplyBlast

Manager/Senior Manager, Statistical Programming

Axsome Therapeutics

4 months ago

3.1 on Glassdoor

New York, NY

Onsite

Full Time

Senior

0 applicants

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About this role

Manager/Senior Manager, Statistical Programming at Axsome Therapeutics

Responsibilities

Serve as lead study programmer on one or more clinical trials
Work in collaboration with Biostatistics and Data Management to ensure the accuracy and reliability of reported results
Develop, validate, and execute SAS programs and macros to generate SDTM and ADaM datasets and presentation-ready TFL outputs
Manage CRO partners to ensure the delivery of datasets and TFL outputs according to project timelines
Develop programming specifications, quality check plans, and provide input on key study-related documents such as the SAP and TFL specifications (mock-ups/shells) and other documents produced by other functions, such as Case Report Forms, Data Management Plans, and Data Transfer Specifications

Skills

Qualifications

Bachelor’s degree in Computer Science, Mathematics, Statistics, Engineering, Life Science, or related disciplineSAS CertificationExperience with CDISC-compliant dataSDTM and ADaM lead experienceExperience with eSubmission data packages

About Axsome Therapeutics

axsome.com

Headquarters

New York, New York, United States

Company Size

201-500 employees

Founded

2012

View Profile

Axsome Therapeutics is a biopharmaceutical company focused on developing novel therapies for central nervous system (CNS) conditions that have limited treatment options. Its pipeline and commercial programs include candidates such as AXS-05, AXS-12 and AXS-14, addressing disorders including major depressive disorder, Alzheimer’s disease agitation, migraine, narcolepsy and fibromyalgia. Axsome emphasizes innovative mechanisms of action and rigorous clinical development to deliver meaningful improvements in patient outcomes. The company is headquartered in New York City and advances programs through regulatory engagement and commercialization efforts.