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Clinical Operations and Regulatory Affairs | 14 Jun 2022

Associate Director of Statistician

Job Title: Associate Director of Statistician
Location: Shanghai

 

Position Overview

HUTCHMED Clinical & Regulatory Stats team is responsible for the development and implementation of trial designs, data analysis, statistical interpretations as well as addressing statistical issues in regulatory submission for Hutch-med all pipeline.

Responsibilities

  • Lead Stats team as first line manager to mentor/coach and support the development and training of statistician.
  • Be responsible for all statistical aspects of clinical development, from phase I trial to registration.
  • Serves as statistical representative in cross-functional team for the strategic planning, execution for product development plan and trial design.
  • Represent Stats team when communication with regulatory agency.
  • Do research activities for innovative statistical methods/ regulatory guidance and applications in clinical trial development.
  • Be responsible for statistical part in protocol, analysis plan and result interpretations of all studies
  • Oversees trial conducts from statistical perspective.
  • Oversee CRO to ensure effective and efficient way of working with high quality standards of their deliverables
  • Plan and manage Stats resource for each study and ensure timely and high quality of stats deliverables.
  • Provide leadership and direction on the development of best practice and good stats process.
  • Develop external connection with consultants and collaborative groups.

Qualifications

  • MSc/PhD in Statistics, Mathematics or other related data science majors
  • Minimum 7 years of industry experience
  • Positive working attitude, excellent communication skills and ability to build strong relationships
  • Knowledge of therapeutic areas, especially knowledge of oncology
  • Knowledge of regulatory requirements and statistical theories as well as innovative study designs
  • Have experience on regulatory interactions and/or submissions
  • Strong leadership skill to lead stats team
  • Knowledge of statistical tools such as SAS, PASS, East
  • Be passion for statistical work

 

If interested, please forward your resume to Joycej@hutch-med.com