Statistical Consultant. Alpha Medical Statistics, formerly AZ.
Nicola is an experienced biostatistician with extensive knowledge of the design and analysis of both early- and late-phase trials, with particular expertise in oncology statistics. While Statistical Science Director at AstraZeneca, she was accountable for the provision of statistical input and strategy to drug development programmes for both oncology and infection, spanning Phase I to IV. Nicola designed and defended the Tagrisso(TM) programme that went from start of Phase I to NDA submission within 3 years, as well as programmes across a range of therapy areas submitted to worldwide regulatory authorities, including FDA and EMA. She was also statistical lead for the Risk Based Monitoring (RBM) programme.
Nicola has a BSc in Mathematics from Cardiff University and an MPhil in Medical Statistics from the University Hospital of Wales, Cardiff.