Senior Biostatistician

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Irfa******

  • United Kingdom 
  • Last Update: 03.07.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
Cambridge, GB
Country
United Kingdom

Category


Clinical Bioinformatics

Description


Main Responsibilities Include

  • Provide sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Also contribute to writing appropriate protocol sections.
  • Provide randomization schemes and appropriate documentation.
  • Provide specifications for analysis database, oversee its development, and assure completeness for use in all programming.
  • Coordinate with programmers and data management personnel as to database maintenance, updating, and documentation.
  • Write / review analysis plans and guide others on the team in its implementation. Define appropriate methods and procedures for statistical analysis.
  • Develop or supervise creation of table and listing specifications. Ensure that proper validation for statistical tables and listings is being implemented.
  • Perform statistical analysis for key efficacy endpoints.
  • Prepare reports, manuscripts, and other documents.
  • Contribute statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents.
  • Interact with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.
  • Understand project budget as it relates to project workscope
  • Lead a project team. This involves conducting team meetings, maintaining project timelines, assessing resource needs, providing resources, and budget preparation. Ensure that SOPs are being followed and that appropriate project documentation is ongoing.

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