工作职责：

Position Summary:
Responsible for the planning and execution of statistical activities in support of clinical studies,managing a team, training the new hires, and interviewing the candidates.

Basic Responsibilities:
1. Study Design and Statistical Sections Writing in Protocol
2. Sample Size and Power Calculation in Different Types of Primary Endpoints
3. Generate the Randomization Number per Protocol
4. Write and Review SAP/TLF Shells
5. Review eCRF, Annotated eCRF
6. Preparing ADaM Specifications
7. Creating and Validating ADaM Datasets
8. Creating and Validating TFLs
9. IDMC/DSMB Supporting as Third Party for a Study
10. Writing SAR and Supporting CSR
11. Blind Review Meeting Preparation
12. Host Study Team Meetings
13. NMPA/FDA Inspection Supporting
14. Train and Develop Junior Staff
15. Communication with Regulatory Agencies
16. Interview
17. Resource Planning and Management

任职资格：

Experience and Capability in At Least 5 of the Following Items:
1. Real and Successful Experience in FDA/NMPA Submission
2. Efficacy ADaM Datasets and Analysis Outputs in Lymphoma Study
3. Statistical Simulation and Be Good at Interpreting the Results
4. Multiple Imputation (Non-monotone or Monotone Missing Data Checking, MaR Patterns,MCMC)
5. Meta Analysis and Meta Regression
6. Pooled Analysis
7. Non-inferiority Margin Determination
8. Equivalence Margin Determination
9. ABE and RSABE Method in BE Study
10. Alpha Spending in Sequential Tests and/or Multiple Primary Endpoints
11. Multiplicity and Type I Error Rate Control
12. MRCT Study Design (Simultaneously or Two-Stage)
13. Bridge Study Design (Weighted z Statistics or Bayesian Approaches)
14. Statistical Modeling in Finding RP2D in Oncology Trials (Bayesian Methods with Joint Assessment of Efficacy and Toxicity)
15. Heterogeneity and Subgroup Analysis
16. Know Well of Oncology Dose Escalation Study Design (3+3, m-TPI, CRM, BOIN, etc.)

QUALIFICATIONS:
· Education
Master or PhD in Statistics, Medical Statistics, Mathematics or other scientific fields
· Experience
6~15 years of experience as statistician with Master degree, or, 4~10 years with PhD degree, preferably in a global

SKILLS REQUIRED:
· Oncology experience is a must
· Fast learning
· Extensive clinical knowledge and strong SAS programming skills
· Good in oral and writing English
· Good in presentation
· Strong sense of and well know about the guidelines in NMPA/FDA
· pharmaceutical/CRO company