RESPONSIBILITIES: The Statistical Programmer Analyst applies intermediate level programming techniques and helps plan, design, develop, implement, and maintain software for the monitoring, reporting, and analysis of clinical trials. Prepares and distributes summarized information to the study team. Reviews and implements data warehouse and database designs.
Develop and validate Tables, Listings, and Graphs according to programming specifications and the Statistical Analysis Plan.
SKILLS: EDUCATION: Bachelor or Master Degree in Science.
SAS: 4 plus years (or 2 plus years with a Masters) SAS/BASE, macros, PROC SQL, advanced data step, PROC REPORT, PROC TABULATE, and basic SAS/GRAPH.
STATISTICS: Knowledge and application of p-values, confidence intervals, linear regression analysis, basic general linear models, frequencies, survival analysis, non-parametric analysis. Must be capable of implementing his/her ideas in clear, efficient SAS code for the purposes of data analysis and reporting.
COMPUTER SYSTEMS: UNIX, edit/execute make-file, Oracle Clinical or equivalent clinical DM system, and relational database theory.
DESKTOP: Basic Word/Excel/PowerPoint.
REGULATORY: Basic knowledge of FDA/ICH guidelines and experience dealing with FDA/regulatory requests preferred. Must have basic knowledge of the software development life cycle.
CLINICAL TRIALS: 2 plus years of pharma/biotech preferred. Have an understanding of Biometrics roles in clinical trials. Must understand the data flow process.
COMMUNICATION: Demonstrate clear and timely written/verbal communication and listening/understanding with the Implementation Team (IT), SP department.