Associate Director of Statistician

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

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