KJC Statistics was founded by Dr. Kevin Joseph Carroll and provides statistical consultancy, strategic regulatory advice and training services to pharmaceutical and biotech drug developers.
Dr. Carroll is now an established independent consultant statistician with more than 25 years of industry experience in drug development across all trial phases and multiple therapeutic areas including oncology, cardiovascular, metabolism, respiratory, CNS and GI.
Dr. Carroll received his Masters in Applied Statistics with Distinction from Sheffield Hallam University, UK and his PhD entitled “Statistical Issues in Oncologic Clinical Drug Development” from the University of East Anglia, UK. He is currently a Honorary Senior Lecturer in Medical Statistics at the University of Sheffield, UK. He joined AstraZeneca (then ICI) Pharmaceuticals in the late 80’s and rose to the position of VP Statistics and Chief Statistician in the second half of the 2000’s.
Dr. Carroll has extensive experience in the design, conduct, analysis and reporting of clinical trials. During his career, he has developed, published and applied innovative, novel statistical methodologies and gained hands on experience in the parametric modelling of survival data and the application of adaptive and Bayesian approaches to trial design and analysis. As a consultant this includes the use of novel decision-based designs in Phase II trials and dose ranging studies to aid effective decision making, and the use of complex staged designs in pivotal Phase II/III and Phase III trials to expedite overall drug development times.
Generating the right data from the right trial and programme design is at the heart of any successful drug development process. And then interpreting what that data means in terms of the critical steps in the decision making process and navigating the subsequently regulatory process from submission through to approval and beyond requires experienced, considered statistical judgement. Dr. Carroll has a wealth of experience in drug development governance and decision making at the highest levels. This includes deep experience in the statistical due diligence of in-licensing opportunities, the establishment and management of IDMCs and Trial Steering Committees for large efficacy and safety outcomes trials, and more than 25 years’ experience analysing and interpreting complex data and shaping the content and strategic direction of multiple new product applications. Dr. Carroll can offer your project the experienced statistical judgement and expertise it deserves.
Successful projects are characterised by the quality, experience and commitment of the experts leading them. With support from KJC Statistics you can be assured that the highest level of statistical expertise and commitment will be maintained throughout, as your success is our success.
Experience with FDA/Advisory Committees and Regulatory Authorities Worldwide
Broad experience with multiple new and supplemental drug applications.
Decades accumulated experience of face-face interactions with health authorities worldwide, including than 50+ FDA, EMA, MHLW meetings on critical drug development issues at the highest levels.
Key Presenter for Sponsor, Brilinta (ticagrelor) for acute coronary syndrome (AstraZeneca) (Cardiovascular and Renal Drugs AC), July 28, 2010
Key Presenter for Sponsor, Symbicort for asthmatic control, 10-11 December 2008 and again 10 March 2010 (AstraZeneca) (Division of Pulmonary Drugs Products AC)
Key Presenter for sponsor, Iressa for advanced non-small cell lung cancer, 3-4 March 2005 (AstraZeneca ) (Division of Oncologic Drug Products AC)
Presenter FDA Public Workshop on Clinical Trial Endpoints in Prostate Cancer, June 21-22, 2004.
Public Presenter, Oncologic Drugs AC, Colorectal Cancer Endpoints. May 3-4, 2004
CHMP SAG and Oral Hearing, Iressa, June 2004
CHMP SAG and Oral Hearing, dapagliflozin, March 2012
Japanese MHLW open public hearing on Iressa, March 2005
Sponsor support, FDA Endocrinologic and Metabolic Drugs Advisory Committee, April 2015
Board Member Statisticians in Pharmaceutical Industry 2012-2015
Board Member of EFPSI (European Federation Statisticians in the Pharmaceutical Industry)
Statisticians in the Pharmaceutical Industry 2013-2015
Research interests include survival analysis, non-inferiority trial design, CV and other safety outcomes trial design, interim and futility analyses, adaptive design and Bayesian methods, decision making in drug development.