（高级）生物统计经理-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.

NATURE & SCOPE
Functione******** a co-owner of a clinical stu******** ClinicalStatistics team deliveries reports together with physician an********operat******** provides trial ******** CRF rev******** data analysisan******** an******** on all innovative pipeline interventional clinicalstudies in collaboration with TA clinical sciences phys******** servesas statistics line representative an******** responsible for holdingCRO/Partners accountable for high quality standards of their activitiesan********.

JOB REQUIREMENTS (* for manager, ** for senior manager)
General:
Goo******** of learning with enthusiasm an******** up with the latestmethods & technologies for clinical trials
Ability to work under pressure.
Academic / Professional Qualification
Essential
Master or PhD in statistic********, mathemat******** or otherrelate******** science majors
Knowledge of the technical an******** requirements relate******** therole
Technical / Skill Training
Essential
Ability to apply statistical expertise to complex problems, problemsolving an******** focus
Goo******** skills an******** in building soun********
Goo******** with colleagues, working in a high efficientan********-functional manner
Desirable
*Knowledge of compound, disease an******** guidance includingGoo******** Practice (GCP) an******** Conference on Harmonization (ICH)guidelines
Working Experience
Essential
Minimum 2 years of multi-national industry experience as a clinicalstatistician
Experience of leading an******** a project
Desirable
**Experience of regulatory interactions and/or submissions
**Experience/knowledge of using CDISC/ADaM

DUTIES & RESPONSIBILITIES (* for manager, ** for senior manager)
Assist with protocol ******** sample size calculat******** protocolan******** report form (CRF) review
Develop Statistical Analysis Plans, including statistical metho********key statistical programming proce******** definition of derive********,data-handling rules an********-ups
*Advise data management staff on database ******** an********responsible for critical data an******** quality review
Prepare randomization specifications an******** randomization components(specification an********). Provide input into planning act********including the preparat******** distribution an******** to therandomization an******** unblinding
Execute independent peer review or QC of statistical ******** e.g.,protocols, Statistical Analysis Plans, Tables, Figures & PatientData L******** statistical reports an******** Study Reports
*Provide support for special comm******** e.g., DMCs includinginpu******** of charters an******** of appropriate blinding
**Leadership on the product so that all work is carrie******** incompliance with HENGRUI standards an******** regulations
**Set up standards (an******** compliance) for statistical work withinthe product
Hol********/Partners accountable for the high quality standards of theirdeliverables
Investigate an******** statistical approaches, for relevant statisticalissues and/or regulatory guidance and/or value demonstration
*Provide consulting services in statistical f******** which includes butnot limite******** study design ******** problem-solving in ********data- examination guidance an********-result explanation.
**Understan******** submission ******** having the ability tocommunicate with experts in CDE in an effective manner.
*Provide statistical trainings to newcomers an******** department colleagues