About Our Team

Nicola (Schmitt) Little

Freelance Consultant Statistician

Prior to establishing Alpha Medical Statistics Ltd. in 2016, Nicola Little spent over 13 years working as a Biostatistician for a large Pharma Company (AstraZeneca). In her most recent role as Statistical Science Director, Nicola was accountable for the provision of statistical input and strategy to drug development programmes, spanning phases I to IV, within the therapeutic areas of Oncology and Infection.
Nicola has defended study designs to worldwide regulatory authorities including the FDA and EMA. Nicola has led the statistical input for several successful submissions and most recently designed and defended the trials for an Oncology programme that took 2 years and 8 months from first subject dosed to approval.

Nicola has presented externally on research interests at statistical meetings including PSI conferences, PSI Oncology meetings, EFSPI and DIA. She has also provided lead statistical expertise to risk-based monitoring, centralised statistical monitoring, in-licensing work, due diligence and advisory boards.

Education: Nicola graduated from Cardiff University with a B.Sc. honours degree in Mathematics and from the College of Medicine with an MPhil in Medical Statistics.
Previous roles: Nicola began her career in the NHS (1999) where she provided statistical consultancy to research fellows within cardiology, cardiovascular surgery, primary care and respiratory medicine. In 2001, Nicola took a secondment to the Medical Data Research Center at St Vincents Hospital, Oregon, where she worked on large CV and public health trials.