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Senior Programmer

Revision Date: 14-APR-2025

Primary Function of Position

Responsible for independently writing, modifying, and maintaining programs in support of moderately complex biostatistics and data management programming tasks at ARA.

Position Description & Responsibilities

A Senior Programmer will be responsible for writing modifying and maintaining programs in support of all programming tasks at ARA, including, but not limited to programs that produce SDTM domains, ADaM/analysis data sets, data listings, summary tables and graphs, and listings or other programmatic outputs in support of data management tasks as specified in Statistical Analysis plans and the relevant specifications documents. They may act as a lead programmer on multiple projects, and as such will be the lead point of contact for timelines and budget for all programming related tasks for that project. They may act as support programmers on other projects simultaneously as assigned. They will be responsible for working on multiple simultaneous projects and managing their own timelines and budgets for assigned tasks. A Senior Programmer will be able to work independently, take initiative for completing tasks and getting support/help when needed. They will provide support and oversight to other, more junior programmers in their role as lead programmers.

A Senior Programmer will serve as the primary programming resource for assigned projects. Senior Programmers will have a clear understanding of the therapeutic area under investigation providing programming guidance to internal and external project team members and will help identify solutions for programming related issues for their projects.

Consulting responsibilities may include support for clients regarding collection of data for clinical trials, statistical and programming methodology and creation and review of CDISC documentation including define.xml and reviewers guides.

May be responsible for mentoring other biostatisticians and programmers in technical aspects of supporting statistical deliverables.

Job Responsibilities

  • Review CRF/Protocol, Data Transfer Agreements and other study documents and provide comments from a programming perspective to support the project.
  • Review and understand SDTM and ADaM Specifications of moderate complexity
  • Create SDTM and ADaM Specifications of average complexity.
  • Perform Production and/or Validation Programming of SDTM domains, ADaM and Analysis datasets and Tables Listings and Figures (TLFs).
  • Perform programming that produces complex data checks or other outputs in support of data review/data management tasks.
  • Perform Ad Hoc programming in support of manuscripts or other deliverables without formal specifications.
  • Prepare and Set up project work areas (including any macros) and project documentation for new projects.
  • Prepare and maintain project documentation related to programming activities including Data Definition Tables, Define.XML, Reviewers Guides and annotation.
  • Prepare/review project documentation and/or memos for external communications in conjunction with the Project Lead.
  • Mentor other members of the biostatistics and programming group in technical aspects of programming.
  • Provide technical programming support to both internal and external project teams.
  • Lead teams of programmers to complete project tasks as assigned per company/client SOPs.
  • Participate in departmental and company process development initiatives, working closely with data management, quality assurance and other staff as required.
  • Maintain current knowledge of FDA regulatory guidelines regarding clinical trial programming and clinical trial data submissions.
  • Contribute to professional activities (meetings, publications) as assignments allow.
  • Other duties as assigned

Job Requirements

  • 5+ years of programming experience in the clinical research setting including relevant internships or a comparable skillset.
  • 2+ years of experience in the pharmaceutical industry as a SAS programmer
  • BS/BA or equivalent preferred
  • BS/BA/MS or PhD in biostatistics or related area is preferred
  • No management/supervisory experience needed.
  • Experience in a service (CRO) type environment is preferred.
  • Strong understanding of and experience with:
    – SAS/Base
    – SAS Macro Facility, including authoring project level macros
    – Database design principles
    – General statistical concepts and procedures
    – Additional SAS modules as required for specific job position. (e.g.,
  • Knowledge of and experience using ODS Graphics and SAS Graph)
  • Knowledge of and experience using ODS to produce output to various destinations (RTF, PDF, Excel, XML)
  • Knowledge of and experience with CDISC Standards
  • Working knowledge of Word Processing software, Microsoft Project, Microsoft Outlook, database software and Spreadsheet software.
  • Excellent written and verbal communication skills including listening, negotiating, technical discussion, and presentation.
  • Proven ability to successfully interface with all levels of employees and management and work successfully in a team environment.
  • Ability to work independently on assigned tasks and proactively seek feedback and guidance when needed.

characteristics

  • Clear, direct communication style
  • Able to work successfully with different personalities and work styles.
  • Dedicated work ethic with attention to results and productivity
  • Strong sense of accountability for company and professional goals
  • Works well under pressure
  • Able to take the initiative when needed, even on unfamiliar tasks.
  • Professional demeanor
  • Possesses a positive attitude.
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