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Director, Biostatistics and Data Management

Oxfordshire   •  Permanent, Full time

CK Group are looking for a talented Director, Biostatistics and Data Management to join an exciting biotechnology company based in Oxford with a very strong product pipeline in pre-clinical and clinical development.

Our client seeks an experienced Biostatistician to lead the development and statistical interpretation of their studies in pre-clinical and clinical development.

This is a fantastic opportunity for someone who wishes to be a principal part of the development process within a small and collaborative team.

Key information

  • Full responsibility and oversight of outsourced activities
  • Biostatistics lead: preparation, review and finalisation of filing documents
  • Review the available data from completed studies and ensure the internal database is built to comply with regulatory standards
  • Collaborate with Clinical Development function in the generation of evidence from completed and ongoing interventional studies, and external collaborations on natural history studies and registries
  • Support Publication Plan with data generation and interpretation

Key requirements

  • Biostatistics industry experience in support of Clinical Development
  • Experience (ideally both FDA and EMA) in preparing regulatory documents and participation in regulatory interactions
  • Expertise in Data Management and experience in building data structures in formats accepted by regulatory agencies
  • English proficiency to write and communicate at a high, professional level

Full job description available upon request

Please quote reference number 50259.

You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Stephanie Maccioni
  • Phone: 01438 743047
  • Reference: 50259
  • Posted: 6th April 2021
  • Expires: 4th May 2021

CK Group

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