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Senior Manager Statistical Programming Jobs in New York

MSD

Senior Statistical Programmer

Rahway, NJ · On-site

The senior statistical programmer will gather and interpret user requirements for programming ... Management, Statistical Programming Preferred Skills: Current Employees apply HERE Current ...

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Senior Manager Statistical Programming information

How does a senior manager statistical programming typically collaborate with cross-functional teams in clinical research projects?

A Senior Manager Statistical Programming plays a pivotal role in coordinating with biostatisticians, clinical data managers, and medical writers to ensure seamless data flow and analysis throughout clinical trials. They oversee programming teams to deliver statistical outputs, such as tables, listings, and figures, while maintaining compliance with regulatory standards. Regular meetings and clear communication are essential, as the Senior Manager must interpret project requirements and translate them into actionable programming tasks, ensuring timelines and quality standards are met. This collaborative environment fosters continuous learning and problem-solving, as cross-functional input is vital for addressing complex data challenges.

What are the key skills and qualifications needed to thrive as a senior manager statistical programming, and why are they important?

To thrive as a Senior Manager Statistical Programming, you need expertise in biostatistics, programming languages like SAS or R, and experience with clinical trial data, typically supported by an advanced degree in a quantitative field. Familiarity with regulatory requirements (e.g., CDISC standards), clinical data management systems, and project management tools is essential. Strong leadership, communication, and problem-solving skills help you lead teams and liaise with cross-functional stakeholders. These skills ensure accurate, compliant data analyses and effective team management for successful clinical trial outcomes.

What is the difference between Senior Manager Statistical Programming vs Statistical Programmer?

AspectSenior Manager Statistical ProgrammingStatistical Programmer
CredentialsBachelor's/Master's in Biostatistics, Computer Science, or related field; often with management experienceBachelor's or Master's in Biostatistics, Statistics, or related field
Work EnvironmentLeads teams, manages projects, collaborates with cross-functional teamsPerforms data analysis, programming, and validation tasks under supervision
Employer & Industry UsagePharmaceutical, biotech companies, CROs, clinical researchPharmaceutical, biotech, clinical research organizations

The main difference is that Senior Manager Statistical Programming oversees teams and manages projects, while Statistical Programmers focus on executing data analysis and programming tasks. The senior role involves leadership responsibilities, whereas the programmer role is more technical and task-oriented.

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Senior Manager Statistical Programming jobs near you
Infographic showing various Senior Manager Statistical Programming job openings in New York as of September 2026, with employment types broken down into 85% Full Time, 14% Part Time, and 1% Contract. Highlights an 81% Physical, 2% Hybrid, and 17% Remote job distribution.

Manager/Senior Manager, Statistical Programming

New York, NY • On-site

Axsome Therapeutics
Biotechnology Research and Development • 1 - 10 employees
Learn more about Axsome Therapeuticsexternal

Full-time

Re-posted 20 days ago

Job description

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 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 is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit 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.
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.

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