Location: United Kingdom (Cambridge) / Sweden (Mölndal)
Salary: Competitive + Excellent Benefits 

We are currently recruiting for a principal statistician to join our growing Statistical Innovation team within our Advanced Analytics Centre (AAC). The Statistical Innovation group is an expert team providing consultancy, capability build and training across a range of clinical statistics areas, including trial design, subgroups, missing data, safety analysis, data exploration & mining, economic modeling and observational research. 

This role is a specialist assignment within Statistical Innovation, which will focus on the statistical aspects of Risk-Based Monitoring (RBM) in large, multi-site clinical trials. It represents a unique opportunity for a motivated and collaborative scientific statistician to help us build a new area within AstraZeneca.
The AAC provides high-end methodological and analytical support to the AstraZeneca drug development organisation, and is a genuinely novel, innovative, exciting and challenging place to work. 

The four AAC skill groups are:

- Statistical Innovation 
- Scientific Computing Solutions 
- Biomedical Informatics 
- Health Informatics 

Key Responsibilities

- Daily consultation with clinical study monitoring teams on interpretation of key risk indicators, and the definition of findings which trigger study monitoring actions 
- Lead the development and implementation of new and existing statistical techniques for RBM 
- Collaborate with study teams to understand importance of different variables, critical-to-quality factors and risk indicators 
- Proactively evaluate and propose the most appropriate statistical approaches 
- Validate new statistical techniques for assessment of risk indicators, post-implementation 
- Drive discussions around refinement of existing risk indicator analyses 
- Interact with the external vendor(s) who are providing RBM support to AstraZeneca 
- Work closely with the AstraZeneca Centralised Monitoring group, including provision of training and guidance 
- Maintain an overview of current relevant initiatives and approaches across AstraZeneca 
- Share knowledge and learnings across the therapy area biometrics teams 
- Participate in related clinical trials statistical initiatives and projects, where time permits 

Skills & Experience

- Experience of clinical drug development, and the role of study and monitoring teams 
- Understanding of Centralised Data Monitoring, Risk Based Monitoring, and their impact on study conduct & integrity 
- Experience of advanced statistical techniques for clinical data monitoring 
- Implementation of risk indicators, and triggers for future actions 
- Understanding of the implications of missing data in this context 
- Predictive modelling to generate expected values/distributions 
- Interpretation of extreme/outlying data in the context of multiplicity 
- Graphical techniques for data appraisal 
- Broad/general knowledge of statistical methods and their application to clinical/medical data 
- Statistical software & programming: R, Spotfire/visualisation, SAS 

About AstraZeneca & Biometrics and Information Sciences 

The Advanced Analytics Centre forms part of our Biometrics and Information Sciences function. 
Biometrics & Information Science unit (B&I) drives good design to generate the data needed for quality decision making on AstraZeneca’s late stage Projects. The goal of B&I is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions. B&I is part of our Global Medicines Development (GMD) division, the area of our business responsible for progressing innovative molecules into medicines. 

As one of the world's leading pharmaceutical companies, AstraZeneca is focused on providing innovative, effective medicines that make a real difference in important areas of healthcare. At AstraZeneca, innovation is about more than just research. We aim to stimulate continued creativity throughout our organisation by maintaining a culture in which our people feel valued, energised and rewarded for their ideas and contribution to our success - ideas which can make a difference in all aspects of our business. And we support and encourage our people in discovering their own potential, through excellent learning and development opportunities that are available to them throughout their careers.

AstraZeneca welcomes applications from all sections of the community.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 

To apply please click below...

http://jobs.astrazeneca.com/jobs/details/l1rRD1477-principal-statistician-risk-based-monitoring

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