Senior Clinical Statistical Programmer
Senior Clinical Statistical Programmer provides end-to-end statistical programming support in planning, specifying, designing, developing, and implementing statistical solutions for the reporting and analysis of clinical trials in accordance with applicable processes.
As a part of existing teams, you will focus on bringing together best-in-class science, technology, and service to drive superior clinical outcome results.
Job responsibilities:
As a member of a clinical project team, the Senior Clinical Statistical Programmer applies advanced-level programming techniques and leadership to the planning, design, development, implementation, and maintenance of software for the monitoring, reporting, and analysis of clinical trials. Designs data warehouse, SCS, and SCE databases. Demonstrate the use, creativity, and ingenuity to solve complex programming problems (e.g., creates reusable code, develop project/department standard code, design interconnected programs).
The Senior Clinical Statistical Programmer will be accountable for overall timelines and major project milestones, as well as overall project quality, integrity, and productivity. May serve on or lead the departmental initiative, specialized projects, and/or working groups. Can serve as a project team leader. This position should be capable of developing and maintaining software development tools and standard templates. Also, this person should be a Subject Matter Expert (SME) as a technology troubleshooter.
General requirements:
- 5+ years of SAS programming experience combined with 3 years of clinical trial experience
- Must possess the knowledge and application of p-values, confidence intervals, linear regression analysis, advanced general linear models, frequencies, survival analysis, non-parametric analysis, and randomization software, and demonstrate proficiency in implementing new ideas in clear, efficient SAS code for the purposes of data analysis and reporting
- Must demonstrate intermediate UNIX, Oracle Clinical or equivalent clinical DM system, and relational database theory
- Must have a basic understanding of the FDA/ICH guidelines, the software development life cycle, 21 CFR Part 11, and other relevant FDA regulations
- It would be an asset to have had experience working on FDA submissions
- Must understand the role of all the functional areas in the clinical trial process
- The candidate should demonstrate clear and timely written and verbal communication with peers, customers, and management
- Should be able to present effective presentations to small groups such as Project Teams or during Statistical Programming meetings