Director, Biostatistics will be responsible for:
• 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.