Associate Director of Biostatistics

Company: Lloyd Staffing ( Learn More )

General Information
US-NJ-Northern New Jersey
At least 5 year(s)
Not Specified
Job Description

Our client, a leading pharmaceutical company has engaged us to help them identify an Associate Director of Biostatistics to join their team and serve as a lead biostatistician for clinical studies and projects. The successful candidate will be responsible for all statistics related activities within drug development from study design to regulatory filings and publications. The current focus is to support Phase III clinical studiesĀ in the Neurology therapeutic area.

Duties will encompass...

  • Review protocols and interface with clinicians related to study requirements, design, analysis, duration etc.
  • Develop statistical documents for multiple clinical trials.
  • Monitor study conduct to proactively address issues to ensure high quality study data.
  • Lead preparation of inputs for regulatory documents and ensure readiness for meetings with health authorities.
  • Direct project team activities and provide biostatistical support to clinical areas.
  • Develop and maintain SOPs.
  • Job Requirements
    • PhD in Biostatistics or Statistics is required.
    • 5+ years of pharmaceutical clinical trial experience required. Experience working in the Neuroscience therapeutic area is preferred.
    • Experience with clinical trial Phase II-III study design and analysis. Regulatory submission experience is a strong plus.
    • Expertise in applying statistical methods.
    • Strong SAS programming skills.
    • Experience wtih Bayesian study designs is an added advantage.
    • Participation in NDA submission activities.
    • Strong analyticial and communications skills required.
    • Must be highly motivated, organized, proactive and self-sufficient.