Andy Kenwright Email & Phone Number

Cambridge, Gb

Amsterdam, North Holland, Nl

Brentford, Middlesex, Gb

Provision of statistical, regulatory and paediatric consultancy to Industry

Oxford, Gb

•. Full Service Provider Business Lead, EU and US•. Global Strategy Lead for global infectious diseases•. Received 5 annual Chief Executive Officer “Rethink Drug Development” awards•. Subject matter expert for paediatrics, regulatory interactions and extrapolation•. Project pediatric rheumatology group• Biomarker Statistician involved in novel personalised healthcare investigations• Lead role on all regulatory filings for pediatrics including a first in class accelerated approval drug gaining EU patent extension and positive US pediatric written request approval• Actively managed contract workers and external vendors to ensure quality targets and budgets are adhered to• Senior statistical consultant on study design and analysis• Devised and presented regulatory training for statisticians course including Rapporteur meeting and FDA Advisory Committee (ADCOM) training• Fronted statistical and programming team relating to MHRA inspections and follow-up• Regular representative in FDA, EMA, PDCO, PRAC, Rapporteur and Co-Rapp, Health Authority meetings and ADCOM prep meetings• Independent Data Monitoring Committee Coordinator and Steering Committee liason• Lead statistician on an Osteoporosis compound involving late stage activities, post approval commitments and FDA adcom (discussions on atypical fractures within the class of compounds)

• Held a pivotal role in Business Development• Ensured timelines were met within budget• Provided expert statistical input into all aspects of trial design and analysis• Constructed relevant SOP’s and ensures all systems and procedures are GxP compliant• Pharmacokinetic analyses and reporting• Clinical Trial Report writing for clients – all sections• Maintained a hands-on role, performing all the tasks of a project statistician and programmer where required

Diss, Norfolk, Gb

• Built from scratch and managed a department of 14 responsible for reporting all phases of clinical trials• Ensured timelines were met within budget• Provided expert statistical input into all aspects of trial design and analysis • Acted as Project Statistician and Project Manager on multiple studies simultaneously• Provided training in hypothesis testing, SAS programming and clinical trial reporting• Constructed relevant SOP’s and ensured all systems and procedures were GxP compliant• Assisted in developing Syne qua non’s business through presentations, bid defence meetings and conferences

Pre-clinical and non-clinical statistical lead

Princeton, New Jersey, Us

Pgc, Applied Statistics

Masters, Physiology And Nutrition

Bsc Applied Biology

Education record