Manager/Senior Manager, Statistical Programming

About the role

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes.

Our industry-leading 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, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States.

Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish.

About This Role

Axsome Therapeutics is seeking a Manager/Senior Manager, Statistical Programming to provide programming support for multiple neurology compounds across all phases of development. This role will serve as lead programmer on assigned clinical trials, working closely with Biostatistics and Data Management.

The Senior Manager, Statistical Programming will apply programming methodology to summary and analysis of 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) as scoped in the Statistical Analysis Plan (SAP) for reporting purposes in the Clinical Study Report (CSR).

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. 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. 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:

• 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, 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
• Develop programming specifications, programming quality check plans, and provide input on key study-related documents such as the SAP and TFL specifications (mock-ups/shells), as well as documents produced by other functions, such as 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., Study Data Reviewer's Guide (SDRG), Analysis Reviewer's Guide (ADRG), define.xml, and Study Data Standardization Plan (SDSP)
• Provide hands-on programming as per study needs, ad hoc analyses, and rapid response to inquiries by regulatory authorities in a timely manner
• 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 within function
• Ensure knowledge transfer during and at the completion of the studies/projects.
• Stay up to date with changes in the programming field. Implements new ideas and advanced processes, where applicable

Requirements / Qualifications

• 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 gained within the pharmaceutical or biotechnology industry, or at a Contract Research Organization (CRO)
• For Senior Manager level 8+ years of SAS programming and/or data analysis experience gained within the pharmaceutical or biotechnology industry, or at a Contract Research Organization (CRO)
• Subject matter expertise on CDISC data standards and proven experience working 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 & Thursday. We are unable to consider candidates who are looking for fully remote roles.

Experience, Knowledge and Skills

• Ability to handle multiple tasks, with competing priorities
• Possesses strong organizational skills, with an ability to manage time and resources to ensure the successful achievement of pre-determined deadlines
• Flexibility in approach, while ensuring the delivery of 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 for assigned clinical trials
• SAS Certification is highly preferred; R or Python programming skills are desirable
• Demonstrated ability to effectively communicate with internal and external stakeholders who may lack familiarity with programming applications in drug development and study outcomes
• Must have excellent communication and presentation skills

Salary & Benefits

• The anticipated salary range for this role is $130,000 - $155,000.
• The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location.
• Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.