Job Description

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.

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