北京招聘

【Role Description】:
？ Establish and provide leadership to the Statistical Programming team to set a culture of excellence and high performance
？ Provide expertise and support to the Clinical Biostatistics Team regarding statistical programming for data analyses of clinical trials and data preparation for regulatory submissions
？ Lead the development of fully documented, validated SAS program following specifications in Statistical Analysis Plan (SAP) to perform planned or ad hoc analyses and prepare data displays including the resulting tables, figures, and listings for inclusion in the Statistical Analysis Report (SAR), clinical study report (CSR) and/or publications
？ Lead the development of fully documented, validated SAS program to generate data to meet regulatory requirement for NDA submission
？ Work collaboratively with internal and external (e.g. CRO) team members to coordinate the planning and execution of day to day programming deliverables
？ Establish best in class processes and standards for the reporting of data
？ Build and lead team of high performing team to meet corporate regulatory, scientific, and business objectives
？ Identify and implement efficient ways and/or innovative technologies of programming to support analysis of clinical data
？ Lead development of department SOPs and WIs
？ Oversee vendors with respect to key performance indicators, metrics, and program level deliverables and timelines
？ Contribute to project budget/resource planning, re-forecasting, and program milestones, along with CPMs and Clinical Operations management

【Responsibilities】:
？ Leads, motivates and drives the performance of the Statistical Programming group to achieve agreed objectives; plans and manages resource needs and coordinates with the Clinical Biostatistics group involved in clinical development and regulatory submission activities
？ Determine the technological directions for statistical programming and establish technology and tool for statistical programming to meet business needs in clinical development and regulatory submission activities
？ Lead development and optimization of programming processes with specific focus on efficiency and quality, while maintaining or exceeding industry best practices
？ Plan and facilitate professional training and development of members within Statistical Programming group
？ Provide leadership in development of creating and flexible sourcing strategies to meet the evolving demands

【Qualifications】
？ Bachelor (in Statistics or equivalent) with 12+ years relevant work experience or MS (in Statistics or equivalent) with 10+ years of relevant work experience;
？ Proficient knowledge of / experience with eDC, SAS, R or any other business or research analytic software;
？ Solid experience in leading statistical programming support for multiple trials, experience with regulatory authority submission preferred;
？ Proven knowledge in drug development and NDA submission;
？ Deep knowledge of data architecture;
？ Good interpersonal and communication skills;
？ Fluent in both oral and written English.

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。