（高级）生物统计师-药物临床试验

BACKGROUND
HENGRUI Medicine Clinical Statistics team is responsible for thedevelopment an******** of innovative trial ******** statisticalmo******** an******** analysis for both oncology an********-oncologyportfolio projects, is expecte******** set strategic direction foraddressing statistical issues in regulatory submission an******** aleading role in interaction/communication with regulatory on statisticalmatters.

DUTIES & RESPONSIBILITIES
• Assist with sample size calculat******** protocol an******** reportform (CRF) review
• Develop Statistical Analysis Plans, including statisticalmetho******** key statistical programming proce******** definition ofderive********, data-handling rules an********-ups
• Advise data management staff on database ******** an********responsible for critical data an******** quality review
• Prepare randomization specifications an******** randomizationcomponents (specification an********). Provide input into planningactivities relate******** the preparation of, distribution of an********to randomization an******** information
• Execute independent peer review or QC of statistical ******** e.g.,protocols, Statistical Analysis Plans, Tables, Figures an******** DataL******** statistical reports, Clinical Study Reports
• Holding CRO/Partners accountable for the high quality standards oftheir deliverables


JOB REQUIREMENTS
Academic / Professional Qualification
Essential
• Master degree in stat******** mathemat******** or other relate********science majors
Desirable
• Ph. D degree in stat******** mathemat******** or other relate********science majors
• Experience of regulatory interactions and/or submissions
Technical / Skill Training
Essential
• Goo******** skills an******** in building soun********
• Goo******** with colleagues, working in a high efficientan********-functional manner
• Ability to apply statistical expertise to complex problems, problemsolving an******** focus
Desirable
• Knowledge of compound, disease an******** guidance includingGoo******** Practice (GCP) an******** Conference on Harmonization (ICH)guidelines
Working Experience
Essential
• Leadership skill to lea******** direct elements of project work
• Accountable for statistical work
Desirable
• Experience/knowledge of using CDISC/ADaM