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• Alderley EdgeSK9
• Posted 19th Mar 2010
• Posted by: Hays Resource Management - Astra Zeneca
• Salary: 300 GBP per annum
• Job Type: Contract
• Reference: 2261491
• This job has been viewed 65 times since it was posted.

Job Description

Accountabilities: Clinical Statisticians

• Application of expert statistical skills and thinking to optimally design a series of clinical studies in a specific therapeutic area or area of expertise (eg clinical pharmacology, discovery medicine, health economics).
• Application of expert statistical thinking to support risk assessment, decision-making processes (eg tollgate decisions, labelling), perform the statistical analysis of data from a series of studies and ensure appropriate interpretation of the results, provide support to the regulatory submissions including specification of overview documents and response to regulatory questions.
• Creatively work with the product strategy and licensing to maximise the market potential of AstraZeneca\'s products ensuring the appropriate target claims and messages are included in the marketing and life cycle management deliverables.
• Lead a study-specific or project-wide delivery team, or be CIS rep, as agreed with management and the project team

Non-clinical Statisticians

• Identification and application statistical methodology to improve the process and provide practical solutions for research/production activities

All statisticians

• Negotiation of time frames for the completion of tasks.
• Delivery of the tasks as agreed and present results effectively.
• Management of statistical work contracted out to a CRO or research collaborator.
• Senior statisticians will require minimal guidance from the GPS or manager.

Business Project Lead

• Effectively co-ordinate the development, maintenance, improvement, deployment and implementation of the tool.

BTMs

• For a particular tool, appropriately apply life cycle management, including identifying improvement opportunities. Additionally, provide support to others (eg, perform validation, write audit responses) in relation to the tool.

Requirements Education and Experience

• Essential BS/BSc in Statistics or related field with experience as a statistician in the health care environment or relevant statistical applications
• Desirable MS/MSc in Statistics or Medical Statistics with experience as a statistician in the health care environment or relevant areas of statistical applications or relevant areas of statistical applications.
• PhD in Statistics with experience as a statistician in the health care environment or relevant areas of statistical applications

Clinical Statisticians

• Study design from more than one phase of drug development or extensive experience of study design for regulatory submissions or extensive experience of study design is a specialised area (eg clinical pharmacology, discovery medicine, health economics).
• They should also have experience of analysis of data from more than one phase of drug development, or extensive experience of regulatory submissions or commercial support or extensive experience in a specialised area (eg clinical pharmacology, discovery medicine, health economics).
• Knowledge of Pharmaceutical drug development and marketing

Non-clinical statisticians

• Extensive experience of experimental design for discovery or production.
• Knowledge of Pharmaceutical drug discovery

All statisticians

• Extensive experience of data analysis in using a variety of statistical techniques, with different types of data and issues, eg continuous, discrete, time to event, missing data, modelling.
• Knowledge/experience of Issues arising in Experimental Design/Clinical Study Design and analysis, Statistical programming in more than one statistical package/language,
• Therapeutic Area or areas or specialist area of expertise (eg clinical pharmacology, discovery medicine, health economics)
• Regulatory and/or Promotional Guidelines
• For Business Tool Manager roles, understanding of the tool and its application within and outside of Biostatistics; competent time-management and project-planning skills.

Skills In addition to the requirements for Statistician: Presentation of statistical issues at external professional meetings Development of applied statistical techniques Coaching and performance management Leadership within area of experience, provide technical support to others Project management Negotiation skills Initiative Consistent demonstration of AstraZeneca Leadership Capabilities at target level.