Senior Statistician
North of England
Long term contract
Clinical Statisticians provide expert statistical contributions to design a series of clinical studies in a specific therapeutic area or area of expertise (e.g. clinical pharmacology, discovery medicine, health economics). They provide expert statistical thinking to: support risk assessment, decision-making processes (e.g. 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, work creatively with the product strategy and licensing to maximise the market potential of products ensuring the appropriate target claims and messages are included in the marketing and life cycle management deliverables
Responsibilities
* Application of expert statistical skills and thinking to optimally design a series of clinical studies in a specific therapeutic area or area of expertise (e.g. clinical pharmacology, discovery medicine, health economics).
* Application of expert statistical thinking to support risk assessment, decision-making processes (e.g. 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 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 the representative, as agreed with management and the project team.
* 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 manager.
Minimum Education
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
Experience Required
Extensive experience of data analysis in using a variety of statistical techniques, with different types of data and issues, e.g. 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 (e.g. clinical pharmacology, discovery medicine, health economics)
Regulatory and/or Promotional Guidelines
For immediate consideration please forward your CV to [log in to unmask] or call...
James Carrera
Manager - Pharmaceutical Division
SEC Pharma
0044 (0) 207 225 6665
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SEC Recruitment Ltd Company registered in England and Wales No. 5808613 - Registered Office: RDL House, 1 Chertsey Road, Woking, Surrey
SEC Recruitment Ltd Company registered in England and Wales No. 5808613 - Registered Office: RDL House, 1 Chertsey Road, Woking, Surrey GU21 5AD.
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