Requirements
- M.S. or Ph.D. (or equivalent) in Statistics or Biostatistics is required.
- Minimum 4 years (Ph.D.) or 8 years (M.S.) pharmaceutical industry experience
- Should possess experience interacting with regulatory agencies (e.g. FDA, MHRA or EMEA).
- Experience managing multiple projects/therapeutic areas.
- Experience in managing external vendors (e.g. contractors, CROs).
- Capability in working independently and lead one or multiple clinical studies.
- Knowledge Solid background of statistics
- Experience of SAS, R and other statistical programming packages to validate key endpoint analysis.
- Possess extensive knowledge of the Drug Development Process.
- Possess extensive knowledge of regulatory policies and procedures.
Work Arrangement
Hybrid
Additional Information
- 3 days Hybrid at Malvern PA
- Continuously seek knowledge regarding most current statistical methods
- Prepare presentations for internal and external audiences (presenting at key statistical meetings)
- The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.