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 smaccioni@ckgroup.co.uk. Please quote reference number 50259.

We'll store this in session so if you're applying for multiple jobs today so you can use this as a base.