The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Abstract Details
Activity Number:
|
111
|
Type:
|
Topic Contributed
|
Date/Time:
|
Monday, August 1, 2011 : 8:30 AM to 10:20 AM
|
Sponsor:
|
Section for Statistical Programmers and Analysts
|
Abstract - #300845 |
Title:
|
Agile Approach to Overcome Evolving Challenges Faced by Statistical Programmers During Clinical Reporting
|
Author(s):
|
Vikash Jain*+
|
Companies:
|
eClinical Solutions
|
Address:
|
250 Michelle Lane, #209, Groton, CT, 06340, u.s.a.
|
Keywords:
|
Statistical ;
Programmer ;
Agile ;
Clinical ;
Reporting ;
quality
|
Abstract:
|
Evolving industry standardization, global competitiveness and economic downturn are driving many pharmaceutical and biotech companies to look into strategic approaches to adopt business models of outsourcing or off shoring or blend of both for their clinical programming operations for reduced cost, maintain quality and minimal turnaround time on their reporting. With such strategic influences our paper will specifically focus on how the statistical programmer's involved in reporting phase are challenged when interacting with external cohesive departments and also challenged internally with in their programming team in operational aspects when most of them are dispersed domestically and/or globally. This paper outlines challenged scenarios faced at various avenues during their course of trial reporting either an individual study or a submission and how they can adopt to such situations proactively by incorporating continuous evaluation & adjustment, subjective judgment with agile thinking and understand their own shared purpose, goal and accountability with in their organization and also with external partnership to maintain the integrity of quality and relationship in a long run.
|
The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
Back to the full JSM 2011 program
|
2011 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.