Contract Statistical Programmer

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 www.axsome.com and follow us on LinkedIn and X . 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

Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS; Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan; Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts; Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) Create electronic submission packages to FDA, e.g., define.xml or define.pdf following FDA guidelines with no supervision. Expert-level in analyze information and develop innovative solutions to programming and data analysis challenges; Serve as point of contact (POC) of programming with statisticians for statistical input and analysis interpretation; Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiatives. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams; Review draft and final production deliverables for project to ensure quality and consistency. Work with global team or sponsors to coordinate project deliverables, timelines and resources. Skills and Responsibilities: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 5+years of clinical programming experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Expert-level in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Expert level in applying concept in Artificial Intelligence and Machine Learning in real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical tria

Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS. Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan. Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts. Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision. Proficient in analyze information and develop innovative solutions to programming and data analysis challenges; Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiative. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams. Review draft and final production deliverables for project to ensure quality and consistency. Skills and Qualifications: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines. Minimum of 4+ years of clinical programming experience, along with 1+ year of project management and 1+ year of people management experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clini

OVERVIEW Experienced Statistical Programmer with expertise in supporting multiple clinical studies through the development, validation, and delivery of high-quality statistical programming outputs. Proficient in SAS (Base SAS, SAS/STAT, and Macro Language) and CDISC standards, including SDTM, ADaM, and TLF development for regulatory submissions. Skilled in creating analysis datasets, safety and efficacy tables, listings, figures, Define.xml, and submission packages compliant with FDA, PMDA, and EMA requirements. Strong knowledge of the clinical drug development process, data automation, safety reporting, DSUR/PSUR deliverables, and Pinnacle 21 validation. Proven ability to collaborate with internal stakeholders, proactively resolve programming issues, and ensure timely, compliant, and accurate study deliverables. Use of R and AI tools to augment, enhance day to day programming is a huge plus. KEY TASKS & RESPONSIBILITIES ➢ Led multiple studies on end-to-end programming while serving as the primary point of contact for clients. ➢ Develop specifications and SAS programs for SDTM datasets and clinical data analysis deliverables. ➢ Create specifications and SAS programs for ADaM datasets supporting trial-level reporting and integrated safety and efficacy analyses. ➢ Develop, maintain, and validate Tables, Listings, and Graphs (TLGs) based on biostatistical requirements and Statistical Analysis Plans (SAPs). ➢ Program and QC data listings, summaries, graphs, and statistical models as required. ➢ Design and maintain reusable SAS macros to support Phase I–IV clinical trial reporting. ➢ Generate submission-ready datasets and output using industry standards, SDLC practices, and regulatory requirements. ➢ Collaborate with cross-functional teams to ensure timely delivery of high-quality study outputs. ➢ Maintain project documentation in compliance with SOPs, processes, and quality standards. ➢ Ensure adherence to eClinical Solutions and industry guidelines, procedures

Job Title: Project Manager Department: Biometrics/Project Management Responsibilities: Manages Biometrics project teams from study start-up through study closeout; departments include Data Management, Biostatistics, Statistical Programming, and Medical Writing. Manages multiple projects ranging in size and complexity from single service studies to large full scope biometrics projects, global projects and/or programs, with minimal oversight from supervisor. Serves as the primary liaison between clients, vendors, and project teams. Promotes team communication and cross functional collaboration in order to promote team spirit. Establishes and maintains relationship between client, vendors and project team, to encourage repeat and/or new business. Coordinates and leads team meetings. Creates and distributes agendas and minutes. Generates and maintains timelines, milestones, and action items. Manages project financials; estimates monthly accruals and initiates timely invoice generation. Identifies change orders items. Oversees issues and facilitates issues resolution, and escalates, when needed. Identify risks, mitigation, maintenance and resolution. Ensures training required internally and by sponsor is completed. Supports contract team with contracts (SOW, WO, COs, etc.) by developing the budgets and scope of work. Provides performance feedback for project team and managers. Supports business development activities (RFPs and RFIs) and governance activities, when required. Performs other tasks as assigned by Sr. PM staff. Skills and Qualifications: Requires a bachelor’s degree or higher in life sciences. MBA or PMP is preferred. Three plus years of experience in Pharma/CRO industry with 3+ Years’ experience in Project Management. Possesses solid knowledge of Biometrics services and inter-dependencies. Knowledge of FDA regulations, drug development and PM processes. Good understanding of ICH/GCP guidelines. Strong communication s

Job Title: Project Manager Department: Biometrics/Project Management Responsibilities: Manages Biometrics project teams from study start-up through study closeout; departments include Data Management, Biostatistics, Statistical Programming, and Medical Writing. Manages multiple projects ranging in size and complexity from single service studies to large full scope biometrics projects, global projects and/or programs, with minimal oversight from supervisor. Serves as the primary liaison between clients, vendors, and project teams. Promotes team communication and cross functional collaboration in order to promote team spirit. Establishes and maintains relationship between client, vendors and project team, to encourage repeat and/or new business. Coordinates and leads team meetings. Creates and distributes agendas and minutes. Generates and maintains timelines, milestones, and action items. Manages project financials; estimates monthly accruals and initiates timely invoice generation. Identifies change orders items. Oversees issues and facilitates issues resolution, and escalates, when needed. Identify risks, mitigation, maintenance and resolution. Ensures training required internally and by sponsor is completed. Supports contract team with contracts (SOW, WO, COs, etc.) by developing the budgets and scope of work. Provides performance feedback for project team and managers. Supports business development activities (RFPs and RFIs) and governance activities, when required. Performs other tasks as assigned by Sr. PM staff. Skills and Qualifications: Requires a bachelor’s degree or higher in life sciences. MBA or PMP is preferred. Three plus years of experience in Pharma/CRO industry with 3+ Years’ experience in Project Management. Possesses solid knowledge of Biometrics services and inter-dependencies. Knowledge of FDA regulations, drug development and PM processes. Good understanding of ICH/GCP guidelines. Strong communication s