>>>Location：Shanghai
【Primary Function】
•Establish and provide leadership to the Biometrics team at Relevance to set a culture of excellence and high performance；
•Provide expertise and guidance to the Clinical Development Team regarding statistical methods for data analyses of clinical trials；
•Provide statistical representation and leadership on project and protocol teams and to regulatory agencies；
•Participate in the protocol development process, including responsibility for sample size / power calculations and the statistical section of the protocol；
•Responsible for preparation of the Statistical Analysis Plan (SAP), 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 SAS program as necessary to perform planned or ad hoc analyses and prepare data displays；
•Lead verification of statistical programs, data sets used and statistical results in regulatory documents and other clinical data reports；
•Participate in the writing, review, and finalization of regulatory documents (for examples, Data Management Plan, Data Management Report, SAPs, SARs, CSRs), abstracts, and manuscripts for publication；
•Participate in regulatory preparation activities including document authorship (e.g. NDA, sNDA), and answering requests from the regulatory agencies (CFDA, FDA, EMEA)；
•Provide statistical interpretation and explanation of results to team members；
•Work collaboratively with internal and external (e.g. CRO) team members to coordinate the planning and execution of day to day biostatistics deliverables；
•Establish best in class processes and standards for the generation and reporting of data；
•Build and lead team of high performing Clinical Data Scientists, Biostatisticians and Programmers to meet corporate regulatory, scientific, and business objectives；
•Lead team in the design, and analysis of clinical studies using appropriate and innovative statistical methods；
•Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives；
•Identify and implement emerging new ways of doing clinical development and new methodologies；
•Lead development of department SOPs；
•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 Biometrics group to achieve agreed objectives; plans and manages resource needs and coordinates the interfaces with the other functions involved in clinical development and life-cycle management；
•Ensure appropriate statistical designs, data collection and analysis tools and processes to clearly and robustly address the objectives of clinical studies and programs；
•Influence and provide good-faith challenge to the broader clinical organization with respect to clinical development decisions and data interpretation；
•Lead development and optimization of Biometrics processes with specific focus on efficiency and quality, while maintaining or exceeding industry best practices；
•Provide leadership in development of creating and flexible sourcing strategies to meet the evolving demands 。
【Qualification】
-Education background-
•MS (in Statistics or equivalent) with 13+ years relevant work experience or PhD (in Statistics or equivalent) with 10+ years of relevant work experience;
-Industry experiences-
•Proficient knowledge of / experience with eDC, SAS,East or any other business or research analytic software;
•Solid experience in leading statistical analytic support for multiple trials, experience with regulatory authority interaction preferred;
•Proven knowledge in drug development and NDA submission;
•Deep knowledge of data architecture;
-Language Skills-
•Fluent English in reading, writing and oral communication；
-Computer Skills-
•Microsoft Office software；
-Other Special requirement-
•Good interpersonal and communication skills.
>>>Contact Information：
联系人：Frank Wang
联系方式：15680922101（微信同号）
邮箱：frank.wang@isaac-kenneth.com
