Director, Biostatistics

Responsibilities:

  • Writing statistical methodology section of the protocol and statistical analysis plans
  • Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities
  • Direct the activities of internal and external statistical programmers
  • Review eCRFs and edit checks documents
  • Support and participate in the preparation of study reports, regulatory submissions, and annual IND safety update reports

Director Biostatistics should have:

  • Ph.D. in statistics or biostatistics
  • At least 10 years of biopharmaceutical statistics experience
  • Experience in late stage drug development, including phase IIb, phase III, and submissions in the pharmaceutical industry
  • Ability to communicate effectively within cross functional project teams
  • Experience in organising regulatory submissions such as BLA, NDA, sNDA, and MAA submissions
  • Good working knowledge of ICH, FDA and GCP regulations and guidelines
  • Experience in oncology
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Director, Biostatistics