Consultant Profile

MW

Melanie Wakelin

Areas of Consultancy:
Bioassay
Calibration
Clinical trials
Design and analysis of experiments

Region of consultancy:
UK

Profile

I am an independent statistical consultant with 25 years experience working as a statistician, mainly in the areas of medical and pharmaceutical research.

Background

I have been working as an independent statistical consultant since 2002 providing statistical consultancy services to many areas of medical research. This has included working with pharmaceutical companies, medical device companies and academia. Prior to working as an independent statistical consultant I worked for a major pharmaceutical company and for a medical diagnostics company, where I was the manager of the statistics and data management department. I have an MSc Biometry (1990), a first class honours degree in statistics and biology (1989) and became a Chartered Statistician in 1995, after being fellow of RSS since 1989. I was one of the first batch of statisticians to have their Chartered status successfully re-validated in April 2014. I am also a member of PSI (Statisticians in the Pharmaceutical Industry).

Specialisms

I mainly work in medical research and have considerable experience in the design and analysis of clinical trials. My involvement in study design and analysis includes trials of medical devices, pharmaceutical products and non-pharmaceutical interventions in primary care. I have been involved in a large number of trials in the areas of women's health and dermatology. Outside of clinical research I also provide consultancy services in relation to non-clinical research and in particular assay development and validation. I have a strong academic background in biology as well as statistics and find that this helps me to rapidly understand the non-statistical aspects as well as the statistical issues in any proposed studies. I have developed and delivered a number of training courses to non-statisticians (scientists in industry and NHS).