Position Summary:

Responsible for the planning and execution of statistical activities in support of clinical studies,

managing a team, training the new hires, and joining the interviews.

Principle Responsibilities:

1, Study design and sample size calculation

2, Statistical simulation

3, Generate the randomization number per Protocol

4, Write and review SAP/TLF shells

5, Review eCRF, annotated eCRF

6, Creating and validating ADaM datasets

7, Creating and validating TFLs

8, IDMC/DSMB supporting

9, Writing SAR and supporting CSR

10, Blind review preparation

11, Host study team meeting

12, CFDI inspection supporting

13, Train and develop junior staff

14, Communication with regulatory agencies

15, Interview

16, Resource management

17, People manager

Principle Relationships:

？ Contacts inside and outside the Company: Biostatistics and Programming, Clinical Team,

Data Management Team, Clinician and Pharmacist Team

上班地址：上海市虹口区花园路66弄嘉和国际大厦1号楼16楼