Job Opportunities

Principal Biostatistician

Department: Biometrics
Job Title: Principal Biostatistician
Report to: Biostatistician Director
Location: China 

MAIN REPONSIBILITIES:

  • Contribute to the study design and sample size calculation
  • Prepare and finalize the statistical analysis plans.
  • Review and comment statistical methods sections and the interpretation of results.
  • Contribute to the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to the type of project.
  • Provide input into general standardization efforts (e.g., CRFs, query checks, statistical methodology, standard statistical programs, data presentations).
  • With direction, interact with regulatory agencies regarding statistical issues.
  • With direction, develop responses to regulatory agency requests that maintain perspective and are within the appropriate context.
  • With limited direction, write accurate, logical, clear, concise, thorough, and objective statistical methods sections for clinical trial reports.
  • Review the clinical trial reports ensuring the accuracy of the statistical interpretation.
  • Provide statistical support for manuscripts and review manuscripts for accurate statistical interpretation.
  • Communicate routine and complex statistical concepts and results to non-statistical internal and external colleagues in a clear, concise, focused, and articulate manner.
  • Participate effectively on clinical trial teams when required.
  • Produce assigned work within the timelines provided ensuring deadlines are met.

QUALIFICATIONS:

  • Ph.D. or MS in Statistics, Biostatistics, or related discipline
  • Fluent in English
  • At least 5 years’ experience in the Pharmaceutical/Biotechnology industry in clinical development
  • Knowledge of relevant regulatory guidelines, ICH Statistical and Clinical Report Guidelines applicable to clinical development.
  • Self-directed, technically strong regarding to clinical and methodological development
  • Good working knowledge of oncology therapeutic areas