Senior Manager/Ad Biostatistics

TMC Software Inc South San Francisco , CA 94080

Posted 2 months ago

  • Participate in strategic planning and develop optimal clinical development plans with cross-functional drug development teams.
  • 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 CDISC standards.
  • Review and comment on eCRFs, annotated eCRFs, edit checks documents and other clinical data management related documents.
  • Participate in operations meetings and address issues related to biostatistics.
  • Support and participate in the preparation of study reports, regulatory submissions and annual IND safety update reports.
  • Perform ad hoc analyses and validation of analysis results.
  • 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.
  • Write simulation code and simulation report in compliance with regulatory agency requirements for adaptive design trials.
Job Requirements
  • Ph.D. in statistics/biostatistics with minimum 6-10 years of biopharmaceutical statistics experience; Masters degree in statistics or biostatistics with a minimum of 8-12 years of 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 adaptive design, 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 team work spirit.
  • Experience in neurology/cardiovascular therapeutic areas is desirable.
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Senior Manager/Ad Biostatistics

TMC Software Inc