Lead Statistician

Lead Statistician

Somerset, NJ

ESSENTIAL DUTIES AND RESPONSIBILITIES

  •  Provide statistical expertise in clinical trials and collaborate with Clinical Research and Medical Writing groups on clinical trial protocols, case report forms, statistical analysis plans and other study related documents
  •  Provide guidance to study statistician in SAP writing, statistical analysis and derived analysis datasets and ensure the accuracy and quality of the statistical analysis output
  • Manage study resources and timeline and ensure the quality delivery of the analysis results in a timely fashion
  •  Provide statistical expertise and advice for submission of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies
  • Have in depth knowledge of FDA, EMEA, and ICH guidelines and regulations and in industry data standards, e.g., CDISC SDTM and ADAM

ESSENTIAL KNOWLEDGE, SKILLS AND EXPERIENCE

  • M.S. or PhD in Statistics or Biostatistics
  •  10+ years for M.S. or 5+ years for PhD of experience in clinical trials for regulatory submissions in pharmaceutical, biotech, or CRO environment
  • Excellent communication and writing skills, good programming skills in SAS, S‐plus or other statistical software, and ability to work in a team environment

 

 

 

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