Working in Biostatistics and Data Programming Management in an Early Phase--Focused CRO

• Activity Number: 344
• Type: Topic Contributed
• Date/Time: Tuesday, August 6, 2013 : 10:30 AM to 12:20 PM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Tamara Cuddy*+
• Companies: Celerion
• Keywords: Data Analysis ; ANOVA ; Data Quality ; Programmer Quality ; Management ; Audits

Abstract

Working in Biostatistics and Data Programming management in an early phase-focused clinical research organization (CRO) presents a great opportunity to use a wide variety of skills that start and end with data analysis. It is essential to have accurate data and analysis in order to interpret clinical trial results. The analysis in clinical trials can range from simple tabulations, summary statistics, or ANOVA analysis, to more complex analysis. The endpoints are often pharmacokinetic, and pharmacodynamic results, as well as safety data such as adverse events, vital signs, clinical laboratories, or ECGs. While it is extremely important to plan the analysis up front, it is equally important to ensure that the data is collected, databased, and analyzed correctly. The efficiencies of the processes and mentorship of the staff performing these tasks is essential to ensure the quality of the data and data analysis. The success of the analysis group at the CRO depends on these as well as the communication and interpersonal skills that are used to communicate with clients and auditors.