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Description

•  Global organisation – top 20 pharma
• Excellent career development opportunities
• Fantastic, modern offices
• Opportunity to work with key internal and external stakeholders on a local and global level

• Applying robust statistical methods to the design of new studies ensuring a thorough analysis of study results and where appropriate coordinating additional analyses.
• This role will help ensure that the phase IIIB/IV studies conducted have the maximum chance of success, are scientifically robust and meet the strategic objectives which have been defined, dedicated statistical input is required
• Ensure consistency in the entire program for an assigned therapy area in terms of key variables, definitions, statistical methods, and presentation of results as well as managing external vendors
• Provide considerations of study objectives, designs, methods of clinical assessments and endpoints, statistical power, and statistical methods for the analysis of clinical data
• Plan and perform additional exploratory analyses of study data as required to ensure the full utilisation of study data and the delivery of data which may help support the key marketing messages
• Statistical responsibility for interaction with Competent Authorities and Ethics Committees to respond to regulatory based questions concerning the statistical considerations behind a study design
• Write the statistical sections of the study protocol in collaboration with the study team biostatistician, and review and sign off the final version.
• Review and provide input into critical documents such as CRFs and Data Validation Plans
• Contribute to the development of detailed statistical analysis plans and output specifications
• Perform and review/QC statistical analyses for clinical studies in accordance with the protocol, statistical analysis plan, good statistical practice, and available regulatory guidelines
• Review statistical contributions to the clinical study report, including review of tables, figures, and listings
• Attend investigator meetings and review publications

• • Degree educated in quantitative or scientific subjects
  • Solid experience in applying statistical methods in biomedical research
  • Advanced knowledge of base SAS & SAS/STAT programming required
  • In-depth familiarity with processes and procedures in data management and SAS programming
  • Advanced knowledge and understanding of current company / industry practices related to the statistical analysis of clinical data
  • Very good understanding of entire drug development process - ability to see the ‘big picture’
  • In-depth knowledge of clinical trials research and drug development programming experience
  • Experience in working effectively with cross-cultural partners
  • Solid experience in applying statistical methods in biomedical research

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