Manager/Senior Manager, Statistical Programming

About this role

<p>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. For more information, please visit us at <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DQQIa-gYpjh8WDA8s-h_cxtiLRzsSWm9ZOooeS2xh8kY8-FumfaVAL8G_hC6J6y6LuXKTBTKoXqd1vp9_5M907w%3D%3D&data=05%7C02%7Cmsiegel%40axsome.com%7Cce46a392b4314bf2fc5408deb4f815db%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C639147174775627723%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=8Fo48ALyrnssdYy4%2BVbWKAQhTeCEGc5cmyBSzP8vp8g%3D&reserved=0"><strong>www.axsome.com</strong></a> and follow us on <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D_1y-uBUKIw3KWJ6Y-geQ15plDCyHIG7Py7UrynaLe_a3Ox38W8ZNivhkg6dSO_EWMIT6bNTFwzm046vzW_oTZatsU1_U7o9NHovDE-a03JE%3D&data=05%7C02%7Cmsiegel%40axsome.com%7Cce46a392b4314bf2fc5408deb4f815db%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C639147174775644537%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=4C2f%2Fj%2BvpOw9U7NfjfsMaC6RQENZqhH2iOoNOtHcW68%3D&reserved=0"><strong>LinkedIn</strong></a> and <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DF1-pkxXL1lZ12X8uiqEChktKQU5vuDQzzM1QTwq95wNWfa9_p27EwyIBpUngNstn&data=05%7C02%7Cmsiegel%40axsome.com%7Cce46a392b4314bf2fc5408deb4f815db%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C639147174775653954%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=VPVZS1hwi%2FXOzbysmv49npTB%2BP04UT7KlZTCMAO1Dqc%3D&reserved=0"><strong>X</strong></a>.</p> <p><strong>About This Role</strong></p> <p>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</p> <p><em>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. </em></p> <p><strong>Job Responsibilities and Duties</strong> include, but are not limited to, the following:</p> <ul> <li>Serve as lead study programmer on one or more clinical trials</li> <li>Work in collaboration with Biostatistics and Data Management to ensure the accuracy and reliability of reported results.</li> <li>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</li> <li>Manage CRO partners to ensure the delivery of datasets and TFL outputs according to project timelines</li> <li>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</li> <li>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)</li> <li>Provide hands-on programming as per study needs, ad hoc analyses, and rapid response to inquiries by regulatory authorities in a timely manner</li> <li>Ensure consistent maintenance of code, logs, and outputs within a regulated…