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I have held several management positions in Biostatistics which were responsible for all statistical aspects of the

assigned projects.  This included not only Statistics, but  Data Management, SAS programming and Quality Control.

 

I spent the first 11 years of my career in statistical programming / data management positions, then earned the Master’s degree in Biostatistics, in 1981.  This has given me  a unique perspective to create smooth transitions between statistical, data management and programming tasks.

 

My most notable personal success, was the submission and

approval of ZANTAC 75, as an OTC product, while at Glaxo.

In addition to having primary responsibility for all statistic issues, I simultaneously managed a team which integrated all of Glaxo’s previous Rx studies (189), for submission as

the OTC ISS.

 

Overall, I have played a major role in about 10 New Drug Applications, and numerous other Phase I to Phase IV studies.

 

I believe the statistician’s role is to interpret data reasonably, not to stick to rigorous academic methodology.

To that end, I encourage collecting the proper data, in an

appropriate way, so that the clinical results are self-evident.

With such data, it is quite easy to apply simple, standard,

FDA-recognized statistical methods.

Statistical Mission