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About the Role

This role provides programming support for multiple neurology compounds across all phases of development. The individual will serve as lead programmer on assigned clinical trials, collaborating with Biostatistics and Data Management. Responsibilities include applying programming methodology to summarize and analyze clinical trial data, developing and utilizing SAS programs and macros to create and validate CDISC Study Data Tabulation Model (SDTM) conformed datasets, Analysis Dataset Model (ADaM) datasets, and Tables, Figures, and Listings (TFLs) for reporting in Clinical Study Reports (CSRs). This position also involves managing Contract Research Organizations (CROs) for programming support, and planning, executing, and quality checking eSubmission packages for data submission to global regulatory authorities. As part of the submission team, this role will provide rapid responses to inquiries from the FDA and other regulatory authorities. This role reports to the Senior Director, Biostatistics.

Responsibilities

Serve as lead study programmer on clinical trials.
Collaborate with Biostatistics and Data Management to ensure 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 for CSRs and regulatory submissions.
Manage CRO partners to ensure timely delivery of datasets and TFL outputs.
Develop programming specifications and programming quality check plans.
Provide input on key study-related documents such as SAP, TFL specifications, Case Report Forms, Data Management Plans, and Data Transfer Specifications.
Lead eSubmission data package planning, execution, and quality checks of eCRT package components (e.g., SDRG, ADRG, define.xml, SDSP).
Provide hands-on programming, ad hoc analyses, and rapid responses to regulatory authority inquiries.
Ensure consistent maintenance of code, logs, and outputs within a regulated environment.
Contribute to the development of Standard Operating Procedures (SOPs), Work Instructions, and templates.
Ensure knowledge transfer during and at the completion of studies/projects.
Stay updated with changes in the programming field and implement new ideas and advanced processes.

Requirements

Bachelor’s degree (BA or BS) in Computer Science, Mathematics, Statistics, Engineering, Life Science, or related discipline.
For Manager level: 5+ years of SAS programming and/or data analysis experience in pharmaceutical, biotechnology, or CRO industry.
For Senior Manager level: 8+ years of SAS programming and/or data analysis experience in pharmaceutical, biotechnology, or CRO industry.
Subject matter expertise on CDISC data standards and proven experience with CDISC-compliant data.
2+ years of SDTM and ADaM lead experience.
Demonstrated experience developing and validating eSubmission data package components for regulatory submissions, amendments, and supplements.
Ability to work on-site Monday, Tuesday, and Thursday.

Skills

Ability to handle multiple tasks with competing priorities.
Strong organizational skills to manage time and resources effectively.
Flexibility in approach while ensuring high-quality work in a dynamic environment.
Ability to oversee and manage a CRO’s CDISC and ADaM dataset-related activities and Table/Figure/Listing programming activities.
SAS Certification (highly preferred).
R or Python programming skills (desirable).
Demonstrated ability to effectively communicate with internal and external stakeholders unfamiliar with programming applications in drug development and study outcomes.
Excellent communication and presentation skills.

Location

New York City
On-site

Work Type

On-site (at least three days per week)

Experience Level

Manager level: 5+ years of SAS programming and/or data analysis experience
Senior Manager level: 8+ years of SAS programming and/or data analysis experience
2+ years of SDTM and ADaM lead experience

Education Level

Bachelor’s degree (BA or BS) in Computer Science, Mathematics, Statistics, Engineering, Life Science, or related discipline

Salary/Compensations

$130,000 - $155,000

Benefits

Annual bonus
Significant equity
Generous benefits package

About the Company

Axsome Therapeutics is a biopharmaceutical company focused on central nervous system (CNS) conditions.
The company identifies critical gaps in care and develops differentiated products with novel mechanisms of action.
Its neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine.
The portfolio also includes multiple novel product candidates for serious neurological and psychiatric conditions impacting over 150 million people in the United States.
Axsome's mission is to solve brain problems so patients and their loved ones can flourish.

Equal Opportunity

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities.
The company values and encourages diversity, soliciting applications from all qualified applicants without regard 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, genetic information, or any other characteristic protected by federal, state, or local law.