Senior Statistical Programmer

About the role

A Senior Statistical Programmer performs advanced programming activities for the statistical and computational considerations of projects, works in a lead programmer role on select moderately complex studies, and provides training and guidance to junior team members.

Responsibilities

• 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, Posters, and Manuscripts.
• Develops ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
• Creates electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines.
• Analyzes information and develops innovative solutions to programming and data analysis challenges.
• Actively communicates with statisticians for statistical input and analysis interpretation.
• Follows and reinforces regulatory agency requirements during daily job.
• Serves as a programming team lead and contributes to department initiative.
• Provides guidance, mentoring, and training for team members and helps solve issues from cross-functional teams.
• 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 3 years of clinical programming experience.
• Advanced SAS programming skills with expert knowledge in SAS/Macro, Proc Report and ODS.
• Good working knowledge in SAS/Graph, Proc SQL, SAS/STAT.
• Proficient in decoding programming logic and assembling programming code based on logic provided and able to explain to team members.
• In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Proficient in Microsoft Office Suite including Word, Excel, and PowerPoint.
• Strong communication skills and coordination skills, ability to communicate with cross-functional or global teams.
• Detail oriented and ability to learn and adapt to changes.