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Dear All, 'DATATECH PHARMACEUTICAL' have the following position.... BIOSTATISTICIAN BASED IN - UK We currently have an opportunity for an experienced Biostatistician to join the Oncology Therapeutic Area, initially on an 11 month contract within International R&D. You will be responsible for ensuring all statistical aspects of documentation pertaining to individual clinical studies meet required standards and are statistically correct, ensuring all statistical aspects of documentation pertaining to non-registrational activities meet required standards and are statistically correct and adhering to all Policies, SOPs and other controlled documents. Key responsibilities: -To co-ordinate the design, statistical analysis and reporting of individual studies -To represent Biostatistics on study teams -To provide statistical input for publications, presentations and in-house decision-making Function as a Study Statistician with the following key activities: -Project-manage all study team activities within Biostatistics according to agreed resource and timeline plans -Create statistical text for study concept documents and protocols (study design, endpoints, sample size, methods for analysis) -Review and approve randomization specifications -Create statistical analysis plans -Create templates for tables, listings and graphs -Review and approve SDF dataset specifications -Review and approve key study-related documents produced by other functions (e.g. CRFs, Data Management Plans etc) -Write, test, validate and execute software programs to produce SDF datasets and tables, listings and graphs (statistical analysis outputs) for inclusion within CSRs, ISS / ISE, IBs, INDs, publications and other communications -Participate in the finalization of protocol deviations and analysis sets -Approve database freeze -Unblind, load and check accuracy of treatment assignment data -Create flash reports or flash memos -Create statistical text for CSRs, clinical publications and other communications -Plan and execute statistical review and QC of CSRs, clinical publications and other communications -Assist in planning and contribute to compilation of ISS/ISE -Oversee the work of outsourcing partners and vendors at study level -Create Requests for Proposals (RFPs) from outsourcing vendors for statistical services -Contribute to decisions on selection of outsourcing partners -Participate in the development and review of Policies, SOPs and other controlled documents -Participate in study and systems audits by CQA and external bodies, and respond to audit questions and findings -Provide input to and participate in intra-departmental and global Biostatistics meetings -Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field -Promote and communicate statistical awareness and the role of the Biostatistics department (internal/external; scientific/process) -Contribute to the continuous improvement of Global Biostatistics You will need as a minimum an MS/MSc or PhD/equivalent in Statistics or other subject with high statistical content and will have demonstrable experience within clinical research of the folllowing:- -Statistical Analysis -Clinical Trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia -Drug Development (Pre-clinical Development, Clinical Development, Medical Affairs) -Fundamentals of Project Planning and Management -Communication of statistical information (written and oral) -International co-operation -Team working -Knowledge -Statistical Methodology and Applications within Drug Development If you fit the above job description please contact Sue Spice at Datatech on 01256 314 640 or email us on [log in to unmask] Alternatively, Refer a Friend or Colleague. Take part in our fantastic referral scheme! If you have a friend or colleague who would be interested in this role, please refer them to us. For each relevant candidate that you introduce to us (there is no limit) and we place, you will be entitled to our generous gift / voucher scheme. FOR MORE DETAILS ON THIS GREAT OPPORTUNITY, PLEASE SEND US YOUR CV TO - [log in to unmask] OR CALL US ON +44 1256 314 640.