Lead Clinical Biostatistician:
Jobot

1320096972
Jobot
Blacksburg Virginia
Pharmaceutical
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Description
Biotech company is looking for a Lead Clinical Biostatistician

This Jobot Job is hosted by: Darwin Porras
Are you a fit? Easy Apply now by clicking the "Apply on company site" button and sending us your resume.
Salary: $80,000 - $120,000 per year

A bit about us:

Based in Blacksburg VA, we are a biotech startup developing an oral first-in-class therapeutics designed to target autoimmune diseases. We are in late clinical-stages focused on the discovery and development of first-in-class oral therapeutics for patients with autoimmune disease. We are looking for a Regulatory Affairs Specialist to join our growing team!

Why join us?

We provide all of our employees with an exceptional compensation package including:
  • Competitive Base Salary
  • Performance based Bonuses
  • PTO
  • Holiday Pay
  • Health, Dental and Vision Insurance
  • 401k matching
Job Details
  • Provide guidance on standards, processes, and technical direction within the biostatistics team.
  • Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements.
  • Design and execute statistical plans independently for all phases of clinical studies, assuming a leadership role in creating strategy for study design and analyses.
  • Review clinical study protocols and Case Report Forms (CRFs) for proposed studies with respect to statistical methodology.
  • Conducting power calculations in preparation for clinical trials.
  • Supervise generation of randomization schemes; supervise unblinding of treatment assignments and appropriate handling of unblinded information.
  • Lead 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/physician.
  • 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.
  • Act as a statistical consultant to the business units and external customers on statistical issues.
Interested in hearing more? Easy Apply now by clicking the "Apply on company site" button.