||Associate Director of Statistician
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.
- 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.
- 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