Effective Collaboration of Statistical Programmers and Clinical Statisticians

• Activity Number: 434
• Type: Roundtables
• Date/Time: Wednesday, August 4, 2010 : 7:00 AM to 8:15 PM
• Sponsor: Section on Statistical Computing
• Author(s): Vipin Arora*+
• Companies: Takeda Global Research & Development Center, Inc.
• Keywords: CDISC ; Statisticians ; Submissions ; Programmers ; Analysis ; Clinical

Abstract

Clinical studies involves early planning and buy-in from stake holders (Clinical Science, Regulatory, Health Authority[[HA] etc.)Statisticians often are involved in early discussion phase but Statistical programmers take on an active role much later. There are many factors for this delayed participation, individual style, level of experience and other project priorities. Programmers and Statisticians are key to success of planning, building and analyzing a high quality database to answer the scientific question to meet the objectives. Updated guidelines and Standards (eg CDISC) are often implemented late stage and cause extra cost and work for project team and therefore result in delays in HA submission/approvals. A proactive approach by Statistical Programmers and Statisticians by providing expert guidance/direction to project team early on is critical for a successful clinical project.