Description
The Senior Biostatistician drives all statistical activities relating to early phase clinical trials across this leading edge diagnostic pipeline (IVD). Ensuring the execution of IVD / Companion diagnostics strategies across the business unit.Day to day you will be providing statistical and data analytic support for the design and analysis of molecular and clinical data to perform high level performance characterization and CVD's (clinical validation studies) that will work in conjunction with IVD device development ad registration.
The ability to work cross functionally will be a key attribute for your application to succeed as this position will see you in collaboration with scientists, clinical therapy experts, physicians and device engineers.
Experience working with DFSS and supporting PMA filings is desired and experience working with Health and regulatory authority's is essential, as is excellent interpersonal and communication skills.
Qualifications
PHD in statistics
Experience in IVD, Devices under control including DFSS, DoE & RSM
Experience in R, SAS or JMP programming languages
8+ years working in a Device, IVD or Biopharma environment.
To find out more about Real please visit www.realstaffing.com