北京招聘

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

Essential

·           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

Essential

·           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

Desirable

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

Working Experience

Essential

·           Minimum 2 years of multi-national industry experience as a clinical statistician

·           Experience of leading and directing a project

Desirable

·           **Experience of regulatory interactions and/or submissions

·           **Experience/knowledge of using CDISC/ADaM

·        Assist with protocol development, sample size calculation, protocol and case report form (CRF) review

·        Develop 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  

江苏恒瑞医药股份有限公司始建于1970年，2000年在上海证券交易所上市，股票代码600276，是国内***的抗肿瘤药和 手术用药的研究和生产基地，国内最具创新能力的大型制药企业之一。 恒瑞医药在连云港、上海、成都、苏州、南京、美国、日本、澳大利亚等地均设有研发中心和分支机 构，目前各类研发人员1800多人，其中有1000多博士、硕士、及海归人士，有5人被列为国家“***”，7人被列入“江苏省高层次创新人才引进计划”，公司 雇员超过17000人。
上海盛迪医药有限公司是江苏恒瑞医药股份有限公司的全资子公司，公司位于上海浦东张江高科技园区，注册成本2.5亿元，占地面积14000平方米。上海盛迪作为恒瑞新药研发的重要组成部分，下设临床医学、中央医学事务、中央市场、临床前开发、新药协调、商务发展、转化医学、对外研发合作等核心职能。