Associate Director of Biostatistics

4 weeks ago

South San Francisco, United States TotalMed, Inc. Full time

Salary: $190,000 to $240,000

On-Site: South San Fran, CA


Responsibilities:


  • Participate in strategic planning and develop optimal clinical development plans with cross-functional drug development teams
  • Oversee all the studies for one compound to ensure the consistency of statistical work standards as the project statistical leader
  • Responsible for writing statistical methodology section of the protocol, including sample size calculation
  • Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS/ISE
  • 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, to ensure the intended analyses are performed, and analysis data sets and their specifications are in place, following STDM standards
  • Review and comment on eCRFs, annotated eCRFs, edit checks documents and other clinical data management related documents
  • Participate in operations meetings, project team meetings, and address issues related to biostatistics
  • Support and participate in the preparation of study reports, regulatory submissions, and annual safety update reports
  • Perform ad hoc analysis and data validation
  • Develop and contribute to Biometrics SOPs and standard working documents meeting regulatory requirements throughout biometrics processes including IWRS/EDC, STDM, statistical programming for TLFs, and data reporting


Qualifications

  • Master’s degree in statistics or biostatistics with 8+ years of biopharmaceutical statistics experience with specific experience in late stage drug development, including phase IIb, phase III, and submissions in the pharmaceutical industry
  • Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time
  • Experience in Biostatistics, SAS programming, and clinical data management in a regulated clinical research environment
  • Knowledge of missing data handling, multiple comparisons, and simulation techniques
  • Experience in organizing regulatory submissions such as BLA, NDA, sNDA, and MAA submissions.
  • Good working knowledge of ICH, FDA and GCP regulations and guidelines
  • Strong leadership skills and teamwork spirit

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