Statistical Consultancy
Dr Kay acts as a consultant for numerous pharmaceutical companies, in relation to study design and the analysis of data, statistical methodology in general, and at a strategic level in support of their regulatory submissions. He regularly supports companies in their interactions with the EMA, FDA and PMDA.
He is experienced in the application of Adaptive Designs and methodologies for interim analyses for efficacy and futility, finding innovative solutions to multiplicity issues. Richard has also worked extensively in Biosimilars, in the use of propensity scoring in non-randomised studies and more recently he has become involved in developments in relation to Estimands and missing data.
Richard has worked on regulatory submissions in many areas including Parkinson’s Disease, Depression, Acute Lymphocytic Leukaemia, Prostate Cancer, Biosimilars in Psoriasis, Therapeutic treatments for Coronavirus, C. Diff. Infection, and in several orphan indications including Ataxia, Primary Haemophagocytic Lymphohistiocytosis (HLH) and Veno-occlusive Disease and Multi-Organ Failure
He is experienced in the application of Adaptive Designs and methodologies for interim analyses for efficacy and futility, finding innovative solutions to multiplicity issues. Richard has also worked extensively in Biosimilars, in the use of propensity scoring in non-randomised studies and more recently he has become involved in developments in relation to Estimands and missing data.
Richard has worked on regulatory submissions in many areas including Parkinson’s Disease, Depression, Acute Lymphocytic Leukaemia, Prostate Cancer, Biosimilars in Psoriasis, Therapeutic treatments for Coronavirus, C. Diff. Infection, and in several orphan indications including Ataxia, Primary Haemophagocytic Lymphohistiocytosis (HLH) and Veno-occlusive Disease and Multi-Organ Failure