CK Clinical are looking for a VP, Biostatistics to join a very exciting small Biotech. This role will be based in the London area with some flexible home working on a permanent basis.
This role will have a unique opportunity to join a company in an exciting phase that has the ability to transform the clinical management of ocular disorders.
·Serve as the lead strategic voice for Biostatics Design and execute statistical plans for all phases of complex clinical studies
·Review protocols, and associated documentation for proposed studies with respect to statistical methodology.
·Generate randomization schemes; unmasked treatment assignments and handle strategy around masked and unmasked information appropriately.
·Support the review and assessment of protocol amendments and all protocol related and downstream activities from a statistical perspective
·Support the review and assessment of protocol deviations to the extent that they affect statistical analyses.
·Produce statistical reports that may be incorporated into internal clinical reports or regulatory submissions.
·Contribute to peer-reviewed articles independently, in coordination with the lead author and the CMO
·Review articles on topics relevant to specified products and provide reports concerning issues relating to statistical methodology.
·Assist with preparation of documentation for IRB/Ethics Committee submissions (e.g., statistical power analysis).
·Assist in the preparation and documentation of results to support trial reports, presentations and publications.
·Resolve complex statistical issues from business units and external customers.
·Provide statistical reports for data quality/performance metrics.
·PhD in Statistics or Biostatistics with clinical development experience in multiple programs.
·Extensive knowledge of statistical methodology including adaptive trial designs and its application to solve problems in the pharmaceuticals/biotechnology setting.
·Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities.
·Strong analytical and problem-solving skills; expert collaboration and communication skills.
·Experience working with gene therapies highly desired.
·Proficient in SAS. Strong programming skills in R, Shiny, Markdown; working knowledge of Git and Unix/Linux environments.
Full job description available upon request.
Entitlement to work in the UK is essential. Please quote reference 49429 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Stephanie Maccioni
- Phone: 01438 743047
- Reference: 49429
Website: CK Group
- Posted: 4th January 2021
- Expires: 1st February 2021