Director, Biostatistics and Data Management
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.
