Independently leads the programming activities for various purposes including CSRs, DSMBs, interim analyses, manuscripts, etc.
Mainly supports statistical programming of statistical analysis plan (SAP)-planned tables, data listings, and graphs for CSRs, as well as integrated summaries of safety and efficacy, ad hoc analyses and electronic submission deliverables, such as datasets, data documentation, programs, programming table of contents, and patient profiles.
Supports migration activities in the creation of Standard Data Tabulation Model (SDTM) and production of the Analysis Data Model (ADaM).
Monitors and meets assigned program milestones, and coordinates and leads a team of programmers to accomplish tasks.
Requirements
Bachelor’s Degree in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 10 years of SAS programming experience with clinical trial data OR Master’s Degree in in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 8 years of SAS programming experience with clinical trial data.
Good working knowledge of CDISC SDTM and ADaM Implementation Guidelines.
Excellent knowledge of regulatory requirements and drug development process.
Excellent organizational skills and verbal/written communication skills.
Ability to work independently as well as lead programming teams.
Strong communication skill set with peers, business partners, and Sponsors.
Strong Analytical mindset.
Leadership skills to lead project team to deliver high quality deliverables on time and working directly with the Sponsor to meet the project delivery expectations.
Must be fluent in English (written and verbal).
Benefits
Flexible, inclusive culture — 70% remote workforce, 66% women-led teams