潍坊招聘

职位描述：
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 (* for manager, ** for senior manager)
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

DUTIES & RESPONSIBILITIES (* for manager, ** for senior manager)
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 举报 分享

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。