BACKGROUND

HENGRUI Medicine Clinical Statistics team is responsible for the development and implementation of innovative trial designs, statistical models, and data analysis for both oncology and non-oncology portfolio projects, is expected to set strategic direction for addressing statistical issues in regulatory submission and plays a leading role in interaction/communication with regulatory on statistical matters.

NATURE & SCOPE

Functioned as a co-owner of a clinical study, Clinical Statistics team deliveries reports together with physician and clinical operation, provides trial design, CRF review, data analysis and interpretation and reports on all innovative pipeline interventional clinical studies in collaboration with TA clinical sciences physicians, serves as statistics line representative and is responsible for holding CRO/Partners accountable for high quality standards of their activities and deliverables.

JOB REQUIREMENTS

General

• Good capability of learning with enthusiasm and keeping up with the latest methods & technologies for clinical trials
• Ability to work under pressure.

Academic / Professional Qualification

• Master or PhD in statistics/biostatistics, mathematics, or other related data science majors
• Knowledge of the technical and regulatory requirements related to the role

Technical / Skill Training

• Ability to apply statistical expertise to complex problems, problem solving and quality focus
• Good communication skills and ability in building sound relationships
• Good collaboration with colleagues, working in a high efficient and cross-functional manner

• Knowledge of compound, disease and regulatory guidance including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

Working Experience

• Minimum 2 years of multi-national industry experience as a clinical statistician
• Experience of leading and directing a project

• Experience of regulatory interactions and/or submissions
• Experience/knowledge of using CDISC/ADaM

DUTIES & RESPONSIBILITIES

• Assist with protocol development, sample size calculation, protocol and case report form (CRF) reviewDevelop Statistical Analysis Plans, including statistical methodology, key statistical programming procedures, definition of derived variables, data-handling rules and mock-ups
• Advise data management staff on database design, and be responsible for critical data and data quality review
• Prepare randomization specifications and verify randomization components (specification and schedule). Provide input into planning activities, including the preparation, distribution and access to the randomization and its unblinding
• Execute independent peer review or QC of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures & Patient Data Listings, statistical reports and Clinical Study Reports
• Provide support for special committees, e.g., DMCs including input/review of charters and maintenance of appropriate blinding
• Leadership on the product so that all work is carried out in compliance with HENGRUI standards and external regulations
• Set up standards (and enforcing compliance) for statistical work within the product
• Hold CRO/Partners accountable for the high quality standards of their deliverables
• Investigate and implement statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration
• Provide consulting services in statistical field, which includes but not limited to study design interpretation, problem-solving in implementation, data- examination guidance and research-result explanation.
• Understand the submission issues, having the ability to communicate with experts in CDE in an effective manner.
• Provide statistical trainings to newcomers and other department colleagues

上班地址：海科路1288号