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Dear Allstat, A leading biopharmaceutical company is looking for a contract Statistician and contract SAS Programmer. These are 1 year contracts ideally to start September / October 2010. Excellent rates of pay. Biostatistician - Key Responsibilities * Informs and suggests solutions to the project statistician on critical issues within trial. * Makes sure that the statistical part of the protocol, the statistical analysis plan and the study reports are reviewed and approved by the project statistician * Discusses protocol and CRF and data transfer specifications with the authors. * Writes 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. * Plans details of the randomization schedule with the appropriate members of the clinical trial team. * Approves the randomization list. * Verifies the consistency of the protocol with the CRF/data transfer specifications. * Ensures that the trial design is compatible with the trial objectives. * Reviews and approves protocol and CRF/data transfer specifications prior to their use or submission to approval committees. * Discusses, reviews and approves protocol amendments * Verifies the appropriateness of the planned analysis and writes the statistical analysis plan. * Authorizes the closure/freezing of the databases and release of the randomization list. * Assesses the impact of subjects withdrawn/lost to follow-up and of the deviations from planned trial design. * Assesses the impact of deviations from distribution assumptions, lack of homogeneity of treatment arms, possible outliers etc. * Documents methods and procedures used in the analysis. * Plans and directs or performs the programming for the protocol specific data reports and statistical evaluations. Assists in programming and/or validation where appropriate. * Discusses and plans model reports, data presentation/statistical evaluation methods and writing responsibilities with the appropriate members of the clinical study team. * Writes the statistical section of reports (CSR, integrated safety/efficacy reports and publications). Reviews and approves the reports. * Verifies adherence to statistical standards and SOPs/PSPs within the study. SAS Programmer - Responsibilities * Informs and suggests solutions to the statistician on critical issues within the project. * Performs the programming for trial or project specific data reports and statistical evaluations in agreement with the guidelines of the statistician, according to the project quality requirements. * Discusses data presentation methods with the appropriate members of the project team. * Performs the programming for standard and special analyses and provides the appropriate members of the project team with trial or project specific listings, summary tabulations and graphics. * Maintains up-to-date documentation for the reporting, analysis and graphics software that is under his responsibility. * Provides technical advice and support to other project team members. * Assesses, recommends and develops new standards, policies and procedures. * Supports computerized systems/subsystems implementation that facilitate the handling and the documentation of trial specific or project specific CRF or non-CRF data, including data flow monitoring and reporting tools, according to the project quality requirements. * In agreement with the statistician, designs and implements trial and project analysis database structures and programs the algorithms that are to be applied to the data for the conversion between different database structures. For a confidential consultation call Laura Christie on 0044 (0) 207 633 4825 or email your CV to [log in to unmask]<blocked::mailto:[log in to unmask]> I look forward to hearing from you. Kind regards, Laura Laura Christie Senior Consultant, Biometrics, Europe Recruiting experts in Pharma HAYS Recruiting experts worldwide 25-27 Wootton Street London SE1 8TG T: +44 207 633 4825 F: +44 207 922 7101 E: [log in to unmask] hayspharma.com ------------------------------------------------ ****************************************************************************** This message (including any attachments) is confidential and may be legally privileged. If you are not the intended recipient, you should not disclose, copy or use any part of it - please delete all copies immediately and notify the Hays Pharma Helpdesk at [log in to unmask] . Any information, statements or opinions contained in this message (including any attachments) are given by the author. They are not given on behalf of Hays Pharma unless subsequently confirmed by an individual other than the author who is duly authorised to represent Hays Pharma. Hays Pharma is a member of the Hays Plc group of companies. Hays Plc is registered in England and Wales, number 2150950. Registered office, 250 Euston Road, London, England, NW1 2AF. ****************************************************************************** You may leave the list at any time by sending the command SIGNOFF allstat to [log in to unmask], leaving the subject line blank.