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
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,