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Dear Subscriber CONTRACT CLINICAL STATISTICIAN TO START JAN 2007 Basic Function: The Statistician is responsible for the biostatistical aspects of Clinical Development projects. On project level this includes development of strategies for clinical development plan with clinical team and interaction with clinical/statistical experts. On study level this includes protocol contributions, case report form definition, scheduling of analyses using the Data Reporting Analysis Manual to help maintaining consistency across the project and finally conducting analyses to providing objective interpretation of results and defence of statistical decisions to clinical team, Life Cycle Team and regulatory health authorities. He/She organizes the workflow and plans and monitors resources. Principle functional responsibilities: Non drug development • Ensures that priorities are consistent with those of Biostatistics • Provides statistical advice and support to members of Biostatistics • Deputizes upon request for the Head of the Statistics Section • Assists in ensuring that statistical standards and SOP’s are followed within the Section • Assesses, recommends and develops new standards, policies and procedures. • Keeps abreast of statistical methodological developments through literature and attendance at meetings. Maintains familiarity with regulatory authority guidelines relating to Biostatistics and with medical issues in own project areas • Maintains proficiency in in-house computer facilities and associated software • Interacts with other departments, including Clinical Science, Regulatory Affairs, Project Management, etc., to ensure good coordination and communication • Maintains contacts with affiliate companies, consultants/contractors, etc. • Assists in ensuring effective communications between staff • Provides input on recruitment of personnel • Assesses, develops and documents new methods and software • Participates in and contributes to internal training programs • Makes presentations at professional forums Drug development • Provides high quality statistical support to clinical projects. • Gives input and ensures that drug development strategy, protocols, CRFs and clinical registration documents are in line with ICH and health authority guidelines as well as company internal SOPs and guidelines. Reviews and approves protocols, CRFs and clinical registration documents. Pays special attention to all statistical issues • Participates in the preparation of drug development plans, especially the clinical development part, and proposes realistic deadlines for statistics tasks. • Ensures that members of drug development team, clinical team and management understand the interpretation of the statistical methods applied to the project • Ensures consistency within project and as far as possible between projects. Assists in the development and maintenance of project standards. Documents agreed Biostatistics policies and procedures. • Plans and requests line management approval for resource allocation for statistical tasks. • Informs and makes recommendations to the Head of Statistics Section on critical issues within the project. Informs management of potential project delays and proposes solutions • Participates, if necessary, in clinical team meetings, project team meetings, study management team meetings and investigator meetings as well as expert meetings and meetings with health authorities • Leads and manages statistical team if acting as project statistician • Ensures that activities performed within a study or project are executed in a timely manner and to the required high statistical and reporting standards • Responsible for the writing of the statistical section of the protocol, stating the hypothesis, defining the planned analysis, primary and secondary variables, time periods, interim analysis specifications, intent-to-treat population and explaining the statistical basis for the choice of sample size. • Writes statistical analysis plan. Ensures that statistical methods, programming algorithms, data presentations, output deliveries, and timing and load of work are sufficient detailed to execute the analysis smoothly • Checks appropriateness of planned analysis. Assesses impact of subjects withdrawn/lost to follow-up and deviations from planned trial design. Checks validity of distribution assumptions and impact of outliers. Documents methods and procedures used in the analysis and decisions made about data handling • Supervises, writes and assists in programming statistical outputs and their validation. • Responsible for the statistical interpretation and the writing of statistical modules for the clinical study report. • Participates in writing publications • Maintains up-to-date project documentation including that of presentation, analysis and graphics software. Key Qualifications and Experiences: • MSc (or equivalent) or PhD in Statistics or very similar area. • Pharmaceutical industry experience in Biostatistics and clinical drug development • Comfortable with Computers; can readily learn new software applications • Experience in using statistical software (particularly SAS) as well as knowledge of database and interface systems. • Very good English language skills. Interpersonal Skills: • Communicates clearly and effectively in written reports, data presentations and meetings as required. • Establishes and maintains good working relationships; is co- operative. Takes cultural and value differences into account in dealings with others. PLEASE CONTACT GLENDA ON 01273 222959 OR EMAIL [log in to unmask]