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.
- 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
- 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
Website: CK Group
- Posted: 6th April 2021
- Expires: 4th May 2021