Principal Statistical Programmer

*Remote Position*

Principal Statistical Programmer

Description

A Principal Statistical Programmer serves as a technical resource for the department, provides programming support and management to multiple clinical trials, and is responsible for the day-to-day management of project activities and deliveries, and ensuring that the deliverables are produced with high levels of quality.

Responsibilities

• Leads and supports statistical programming activities for clinical studies, submissions, and development initiatives.
• Contributes to and manages timelines and work product required to deliver high quality statistical programming services.
• Develops programming efficiencies to ensure a productive work environment producing deliverables of high quality.
• Mentors junior statistical programmers in programming methodologies and relevant company SOPs.
• Lead aspects of the statistical programming including:
• Contributes to the electronic submission of clinical trial data to regulatory authorities
• Annotates Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.
• Develops SDTM specifications and generates SDTM datasets using SAS.
• Develops ADaM,specifications and generates ADaM datasets using SAS based on Statistical Analysis Plan.
• Develops Tables, Listings, Graphs, and Patient Profiles in support of the Clinical Study Report, Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE), Posters, and Manuscripts.
• Creates electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines.
• Reviews draft and final production deliverables for project to ensure quality and consistency.
  
  

Qualifications

• Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, or related scientific disciplines that provides computer literacy and numeracy, and 6 years of clinical programming experience
• Expert level SAS programming skills including SQL and macro development.
• Expert level knowledge and application of CDISC standards for SDTM and ADaM.
• A successful history of cross-functional collaboration.
• Excellent verbal and written communication skills.
• Excellent planning and organizational skills with the ability to adapt and adjust to changing priorities.
• Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment.
  
  

Please submit your application (resume, cover letter) to HR@DuBuResearch.com

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