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Clinical Programming Manager

The Manager of Clinical Programming will provide leadership in the creation and validation of SAS programs in support of sponsor’s clinical trials; ensuring that the SOPs and guidelines are followed in creating the derived clinical databases and data displays to high quality and per agreed timelines. The Manager will provide direction to statistical programmers, programmers, and biometricians in creating sponsor deliverables, and will act as lead programmer for regulatory submissions.

Reporting directly to the Director of Clinical Programming, the Manager of Clinical Programming’s primary responsibilities include the following:

  • Contributing member of CDO Clinical Programming Leadership team
  • Proactively assess and offer input to the Leadership team regarding programming resource
  • Overseeing the daily tasks associated with clinical programming and subsequent analysis to ensure sponsor deliverables are created per agreed timelines and to high quality
  • Adept at managing multiple competing projects including planning, communication, training, and resources
  • Organize, plan, and prioritize work to develop specific goals across assigned sponsor projects and plans to prioritize, organize, and accomplish individual project objectives including generating and maintain key milestone reports
  • Recognizes scope changes. Quantify and assess the impact of scope changes on cost and schedule.
  • Relays change order effectively to Clinical Project Manager.
  • Prepares staffing needs and updates management on a weekly basis.
  • Work with other team members to ensure sponsor deliverables are correct and complete
  • Communicate and collaborate effectively with cross functional teams including but not limited to DIS, Statistics, Data Management, and Project management to ensure smooth execution of projects
  • Monitor projects to ensure that SOPs are properly followed and documentation is completed
  • Ensure project specifications and documentation are correct and complete
  • Lead by example, act as lead or QC programmer in some capacity on assigned projects
  • Assist in the candidate search (resume review) and interviewing process
  • Contributes towards annual review process
  • Additional Responsibilities
    • Mentor and train others in programming and program coding
    • Training programmers and others on programming best practices, processes, procedures, regulations, and guidances
    • Lead group initiatives as assigned by CDO leadership. These may include but are not limited to SOP revision or development, technology recommendations and implementation, process improvement, and macro development

The successful candidate will have a combination of the following skills/experience:

  • Bachelors Degree or Masters Degree in a related discipline or related experience 
  • Minimum 7 + years of experience in a pharmaceutical or clinical research setting as senior SAS or statistical programmer 
  • Minimum 2 + years of management experience required, previous project leader or lead programmer experience will also be considered  
  • Extensive knowledge of SAS programming, SDTM, ADaM, FDA, and ICH guidance. 
  • Communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email

Octagon is an Equal Opportunity Employer with an outstanding corporate culture. We are an emerging growth company providing a business casual environment, strong benefits, competitive compensation and outstanding career advancement opportunities.  The entrepreneurial setting, coupled with our financial stability, has made us an employer of choice, and one of the most sought after Life Sciences employers in the area. Please visit us at www.octagonresearch.com to learn more about how we are revolutionizing the drug development lifecycle.

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