Principal SAS Programmer
Summary of Job Responsibilities:
The Principal SAS Programmer independently leads the programming activities for a trial, early phase project, indication, or publication activities on all level complexity clinical trial projects. As a technical expert, this person will develop and support statistical programming computer systems that are used in the production of statistical analysis plan (SAP) tables, data listings, and graphs, 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. This person is also responsible for monitoring and meeting assigned program milestones, and will coordinate and lead a team of statistical in-house or consultant programmers to accomplish tasks.
Essential functions include creating systems that assist the biostatistical programming staff and biostatistical staff in creating tables, data listings, graphs, and analyses for final reports, abstracts, posters, manuscripts, and other clinical publications; developing systems to support electronic regulatory submissions; providing systems and support for clinical data management staff, clinical programmers, quality control (QC) staff, and biostatisticians; producing and supporting systems that extract data from the clinical database; building analysis databases composed of SAS datasets; consulting with clients on technical and/or regulatory issues; providing technical training to other staff members; and coordinating quality improvement initiatives.
The Principal SAS Programmer must follow established standardized design and programming procedures; mentor and train junior-level SAS programmers; assist in establishing standardized programming procedures and work instructions; develop, enhance, evaluate, and validate standardized macros and utility programs; ensure that regulatory requirements are met through validation/compliance activities; develop and maintain clinical processing work flow systems; assist in the development of client proposal documents; and represent Veristat at client technical meetings.
- BS or MS degree in Computer Science, Statistics, or related health science field with a minimum of 8 years of SAS programming experience with clinical trial data.
- Excellent knowledge of regulatory requirements and drug development process.
- Excellent organizational skills and verbal/written communication skills.
- Ability to work independently and lead others.