Manager/Senior Manager, Statistical Programming

Axsome Therapeutics•New York, NY

3d•$130,000 - $155,000•Hybrid

About The Position

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.

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 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.

Nice To Haves

SAS Certification is highly preferred; R or Python programming skills are desirable
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
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

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, 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