Creation of an online repository for storage of regulatory standard validation material for R packages
The use of R in pharmaceutical research is restricted by a fear of using "un-validated" software resulting in rejected submissions from the industry regulators, but times are changing. Pharmaceutical statisticians supported by R-consortium funding and industry funding through the Transcelerate project are working on the provision of a validation framework which will help users to be able to quantify the risk of using a package. Whilst each user or company will still have to justify the level of risk they are willing to accept before using a package, it is hoped that a collaboration site containing key validation metrics, which are available to all and accessible through pharmaR.github.io, will allow all R users to make an informed choice before using a package. The site will also provide users with downloadable evidence that can substantiate their level of trust that a package is functioning as expected.
Lyn Taylor received her B.Sc. in Applied Statistics from Sheffield Hallam University, her M.Sc. in Medical Statistics from Leicester University and her Ph.D. in Statistical Modelling of Markers of Severity in Rheumatoid Arthritis from Sheffield University. Lyn has worked in medical research for over 17 years, starting out at SmithKline Beecham in the pre-clinical statistics group before moving into the world of CRO’s. After 11 years at PAREXEL and 3 years at PRA Health Sciences as an Associate Director and Senior principal Biostatistician, Lyn will become the Sheffield Office Manager of the new Phastar office starting in Feb 2019. Lyn is the chairperson for the Sheffield local group RSS, co-ordinates the Statistical Activity Network in Sheffield (SANS) and was on PSI CALC before joining the PSI Statistical computing committee which is now the PSI AIMS SIG. Through the AIMS SIG, Lyn is working with a team to set up a Web page on GitHub containing documentation regarding R package Validation. Lyn’s current statistical interests including multivariate modelling, estimands and the use of R in industry.
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