BOL

The Role

My client provide innovative biomarker discovery and development services to the pharmaceutical industry. They partner with the pharmaceutical industry to develop and implement biomarker strategies, providing a full range of biomarker services from pre-clinical biomarker discovery, assay development, right through to the delivery of clinical tests in their CLIA lab.

As a Senior Statistician you would support this effort and be responsible for the management of technical experimental study design and data handling processes required for the discovery, development and commercial delivery of multiplex clinical diagnostic assays; You will:

Develop analytical experimental designs for multiplex clinical diagnostic assays in accordance with regulatory requirements (e.g. CLIA, FDA)
Lead and coordinate the evaluation of analytical studies including characterization, verification, and validation studies
Lead specification setting and specification alterations
Ensure DOE methodology is routinely used in analytical studies.
Work with the Operations Department to ensure robust, reproducible and precise assay development
Provide expertise of general aspects for Statistical Process Control
Provide statistical expertise for R&D, Quality, and Manufacturing
You will work in a fast-paced, project orientated environment and the ability to plan and execute objectives under tight timelines is a must. This is a unique opportunity suited for a qualified statistician with an interest in working to deliver first class data analysis support and solutions in a clinical setting.

Requirements

MSc or PhD in statistics or a related discipline
In depth knowledge of DOE methods to analytically validate, monitor and trouble shoot multiplex clinical diagnostic assays, ideally in a commercial/industrial setting
Experienced in the analysis of statistical technology evaluation, independent data and dependent data analysis, medical diagnostic accuracy, statistical graphics and reproducible reporting.
Excellent interpersonal, communication (including written and spoken English)
Ability to independently manage multiple projects and to deliver results on time per project deadlines
Proficient programming and analysis skills in one or more statistical package (e.g. R, Stata, SAS)
The following skills, while not mandatory, are highly desirable:

Development and validation of predictive models
Experience of clinical epidemiology, survival analysis, biomarker research, Bayesian methods, quantifying predictive accuracy.
Knowledge of regulatory standards for CLIA and/or FDA IVD tests
Reward

An attractive remuneration package will reflect the importance of this role and will include 6.8 weeks annual leave (pro rata, including fixed closure days), company pension scheme, enhanced sick pay and maternity entitlements, healthcare plan and opportunities for learning and development, as well as access to a company restaurant and parking facilities