The Button Builders: What to Expect From Your Statistician

Appropriate software and computing power are indispensable tools to clinical trials and, once programmed, a well-structured set of clinical trial final reports can be generated easily. However, someone has to set up all the unique calculations, data manipulations and output formatting that makes this possible.

Your statistician is doing a whole set of tasks behind the scene in preparation for these easily generated reports, such as:
[x] Writing the statistical analysis plan (SAP), including
....[a] Text descriptions of each endpoint and how it will be analyzed,
....[b] Mock tables and listings which become part of the final clinical trial report (click here for a free copy of the FDA guidance on final reports).
[x] Studying the annotated case report forms and protocol.
[x] Create and validate the programs that will do the analysis.
[x] Revalidate the program whenever it is changed.
[x] Revalidate the program whenever data are added or changed.
[x] Prepare the tables and listings.
[x] Return data and programming to client.

Take this e-conference to learn the processes and steps involved in making these important statistical reports – what’s behind that button.

Learning Objective
You will learn the details behind the study data, the programs used to create the analysis variables and the validation involved in the process.

You will receive
[x] PowerPoint slides.
[x] Ability to estimate timelines required to create and validate programs.
[x] Ability to estimate timelines involved to create tables and listings.
[x] Detailed examples explaining the process from paper forms to FDA submission.
[x] An expert speaker.
[x] Opportunity for QnA.
[x] CEUs and certificate of attendance.

Audience suitability
[x] People who manage clinical trials.
[x] People who work for data management centers.
[x] Statisticians who work on clinical trials.
[x] Managers of clinical trials.
[x] Regulatory professionals who report clinical data

Presenter
Michelle Secic is the President of Secic Statistical Consulting, Inc. She has over 17 years of experience in Biostatistics, has co-authored over 50 articles in the medical journals, and co-authored a book titled, "How to Report Statistics in Medicine" which was translated into Chinese in 2002 and is currently in its 2nd Edition, published by the American College of Physicians in 2006. She can be reached at consult@secicstats.com or http://www.secicstats.com/.

The purchase is $424 for OnDemand access and $474 for the CD. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.