北京招聘

Position Title: Clinical Statistician/ Biostatistician

?Job Purpose:

1. 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.

Duties& Responsibilities

1. Assist with protocol development, sample size calculation, protocol and case report form (CRF) review
2. Develop Statistical Analysis Plans, including statistical methodology, key statistical programming procedures, definition of derived variables, data-handling rules and mock-ups
3. 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 unbinding
4. Provide support for special committees, e.g., DMCs including input/review of charters and maintenance of appropriate blinding
5. Set up standards (and enforcing compliance) for statistical work within the product
6. Hold CRO/Partners accountable for the high quality standards of their deliverables
7. Investigate and implement statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration
8. 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.

Job Requirements

1. Master or PhD in statistics/biostatistics, mathematics, or other related data science majors;
2. Ability to apply statistical expertise to complex problems, problem solving and quality focus;
3. Knowledge of compound, disease and regulatory guidance including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines;
4. Experience/knowledge of using CDISC/ADaM
5. Good communication skills and ability in building sound relationships
6. Good collaboration with colleagues, working in a high efficient and cross-functional manner;
7. Ability to work under pressure and manage multiple projects simultaneously.

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。