Job Listing

Associate Director, Biostatistics

Job Type



Full Time

Provide Statistical Input into clinical development plans, study reports, regulatory documents and publications ensuring accurate deliverables.

Job Responsibilities

  • Provide Statistical Input into clinical development plans, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables
  • Perform Sample size calculations, develop statistical analysis plans and lead TLF development
  • Perform Statistical analyses and validate analysis results
  • Oversee outsourced statistical CRO activities and deliverables ensuring highest quality
  • Develop, implement and improve statistical processes and standards
  • Support and participate in the development of departmental strategies
  • Interact with Global regulatory authorities


  • PhD or Masters in Statistics or Biostatistics
  • 6+ years of experience in the Pharmaceutical Industry and/or CRO including submission experience
  • Excellent knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH,FDA,EMA) and statistical software like SAS, EAST, and R
  • Awareness of the bigger picture, strong orientation to quality, innovate and solution thinking
  • Preferred experience with clinical study designs in Oncology
February 24, 2023