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AD/Director of Biostatistics

  • Job type: Permanent
  • Location: Charlotte
  • Salary: $180000 - $205000 per annum, Benefits: complete benefits package + bonus
  • Job reference: MASL1252018429
  • Sector: Biostatistics, EPM Scientific
  • Date posted: 25/01/2018
An innovative Biopharm company is looking to add an AD/Director of Biostatistics to their Biometrics group due to rapid expansion. If you have experience working on Phase I-IV clinical trials in the Life Sciences industry, are a self-starter, and want to be a part of groundbreaking projects, this is the job for you. 

The AD/Director of Biostatistics will serve as a functional statistical lead on clinical development projects. This role will work in conjunction with biostatisticians, data managers, and programmers within all phases of clinical studies.

Responsibilities: 
  • Manage multiple levels of personnel within the Biostatistics function to develop and execute statistical strategy, design, and analyses of clinical trials
  • Management of CROs and their timelines for delivery of analysis 
  • Set standards and guidelines for CROs to ensure quality
  • Work in conjunction with the department head, peer management, and employees to develop while following department standards and management 
  • Design of statistical methods 
  • Correspondance with regulatory agencies 
  • Work collaboratively in all stages of clinical trials
  • Convey study results to internal and external groups 
  • Troubleshooting statistical methods 
The Ideal candidate will have: 
  • PhD or Master's Degree in Statistics, Mathematics, or related fields
  • 8+ years of experience in pharmaceutical or biotechnology industry is required
  • Strong knowledge of clinical trial design, sound understanding of statistical applications for clinical trials
  • extensive knowledge of drug development regulations pertinent to the statistical analysis
  • experience in contributing to NDAs/BLAs submission and defense preferred
  • Proficient SAS programming skills, solid understanding of CDISC models and standards
  • Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills
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