Senior Principal Statistical Scientist

China, Shanghai, Shanghai
China, Beijing, Beijing

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The Senior Principal Statistical Scientist is responsible for providing statistics expertise and strategic drug development leadership for the most complex and high impact clinical development projects, portfolio-wide initiatives, research applications, development science applications, and/or product manufacturing applications. Their accountabilities typically extend to representing all Biometrics functions on highly visible global development teams and other cross-functional expert groups across the Pharma Development organization.

Accountabilities

Clinical Development

  • Operates at the Global Development Team level, either as Project Lead Statistician or as the sole representative for Biometrics functions on a Global Development Team.
  • Provides statistical leadership for clinical development projects, including providing strategic input into clinical development plans, target product profiles, and integrated evidence plans.
  • Directly responsible for the statistical integrity, adequacy, and accuracy of the clinical studies within the project, including activities to support personal healthcare strategy and governance committee decision making.
  • Provides analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling.
  • May serve as lead statistician for one or more study management teams, with the incumbent responsibilities and accountabilities.
  • Leads cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation.
  • Company Biostatistics lead for Health Authority interactions.
  • Oversees the deliverables from Statistical functional CROs and FSPs and provides leadership, oversight and guidance to CRO statisticians representing Biostatistics at all levels.
  • Serves as member of business development due diligence efforts.
  • Proactively advises teams and functions on overall data strategy and the best application of statistical methods including advanced analytics and relevant data types.
  • Leads and drives partnerships with other analytical functions, focusing on the application of methods that are appropriate to the data type and analysis context.

Functional Area

  • Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, etc.
  • Leads Biostatistics and cross-functional initiatives.
  • Leads the development of functional processes.
  • Recognized expertise in clinical trials and statistical methodology for a clinical indication and/or statistical methodology for specialized applications.
  • Mentors statisticians on request.