Director, Biostatistics and Data Management

  • Salary: £80,000+
  • REF Number: 00050259
  • Consultant: Stephanie Maccioni
  • Contact: 01438 768713
  • Date Published: 06.04.2021
  • Sector:
  • Location: Oxford, with flexible home working, Oxon/Wilts
  • Discipline:

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 experiencedBiostatistician 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 levelFull job description available upon request

Entitlement to work in the UK is essential. For more information, please contact Stephanie Maccioni on 01438 768713 or email Please quote reference number 50259.

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