Principal Statistical Programmer

About the role

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.
• Leads 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.