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Dear Allstat AstraZeneca are currently looking for a contract Statistician who is available to start as soon as possible for 11 months. The role is based at the Alderley Park, Cheshire site however flexible home working will be considered. Please get in touch for further information if this vacancy is of interest to you. Description: Senior Statisticians provide statistical expertise to the design and interpretation of clinical studies and programmes of studies under the guidance of more senior staff (eg, Global Product Statistician (GPS)). They provide direction and statistical oversight to outsourcing partners/providers regarding requirements and standards for study-level work. They engage in analyses to exploit information to improve design and decision-making. They support the GPS in benefit, risk, value and uncertainty assessment. They take on responsibility for components of regulatory submissions including specification and construction of overview documents and responses to regulatory questions, health technology assessment, and commercial exploitation of AZ products. Accountabilities/Responsibilities: • Analysis of internal and external information to inform design decisions (e.g. evaluation of biomarkers as potential diagnostics for a PHC approach, evaluation of potential outcome measures, meta analysis of data to provide characteristics to define noninferiority criteria) • Application of statistical skills and thinking to develop design options that address cost time uncertainty and probability of success with the appropriate use of modelling and simulation or other techniques to enable the business to make informed decisions. • Providing specifications and direction to outsourcing partners/providers to ensure clarity and appropriateness of specifications and standards, early resolution of emerging issues. They hold partners and providers accountable for the quality of their deliverable. • Application of statistical skills to provide support to the regulatory submissions including specification of overview documents and response to regulatory questions. • Application of expert statistical skills to support value demonstration and commercialisation of the product including Health Technology Assessment (HTA), Patient Reported Outcomes (PRO) utilisation and global publication team activities. • Leadership of Statistical contribution for a well-defined area as delegated by GPS and agreed with manager as a lead statistician or lead modeller • Leadership of a small improvement projects. • Leadership of a statistical contribution to a well-defined area as delegated by a Statistical Expert and agreed with their manager as a lead statistician • Contributing to the development, sharing and/or statistical support of new procedures, tools or techniques in order that the quality, efficiency or effectiveness of the Group is improved. • Identifies and applies statistical methodology to improve the methodology and provide practical solutions for clinical development activities • Network with colleagues and experts, providing statistical expertise and serving as a resource for others by sharing experience within and beyond project team. • Negotiates time frames for the completion of tasks Minimum Requirements –Education and Experience: • Essential – 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 BS/BSc in Statistics or related field with experience as a statistician in the health care environment or relevant statistical applications • Desirable – PhD in Statistics with experience as a statistician in the health care environment or relevant areas of statistical applications And • 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 (Safety evaluation, RWE, HTA, clinical discovery interface, modelling and simulation). • 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 (Knowledge of Pharmaceutical drug development and marketing) • Application of statistical techniques in the analysis of data from clinical studies or other relevant areas • Ability to communicate complex statistical concepts to non-statisticians both verbally and in writing. If you are interested in this role please send your CV to [log in to unmask] or call me on 01625 519700. You may leave the list at any time by sending the command SIGNOFF allstat to [log in to unmask], leaving the subject line blank.