o Provide effective leadership and direction to the project team to achieve the business objectives and goals

o Ensure the project is completed within budget, schedule and according to contract specifications and adhere to

quality standards, SOPs, ICH and/or other guidelines and regulations

o Determine the cause of project overruns, recommend and institute corrective action, with input from functional

experts, escalate and follow-up as appropriate

o Ensure maintenance of SA project documentation on an ongoing basis throughout the course of a project

o Prepare, participate in and follow up audits/inspections

o Effectively communicate with internal and external customers as well as third party vendors and clients

o Provide input to proposals and attend Bid Defense meetings as required

o As needed, participate in a meeting with Business Development to understand the scope of the contract and any

Master Service Agreement in place for the client

o Provide Performance feedback and mentor team members

o Prepares analysis plans and writes detailed specifications for analysis files, consistency checks, tables and figures

o Support clinical study report writing

o Support other department by providing statistical expertise for issues in clinical research

o Support Business Development

o Sample Size Calculation

o Update knowledge in statistical concepts, methods and techniques

o Communicates with Clients regarding statistical analysis issues

o Verify statistical programs, statistical results and data sets used in statistical section of technical documents

o Performs quality control procedures on SAS programs

o Mentors other programmers regarding processes, best practices and techniques

o Co-operate in further development of internal manuals and SOPs

o Be trained in client SOPs and disseminate knowledge to the biostat project team members, as appropriate

o Ensure all team members have access to tools and documents

任职要求：

o Bachelor’s degree in Statistics, Science or industry-related discipline

o 5 years substantial and related experience in statistics in clinical research

o Ability to apply statistical methodology to well-formulated problems in the clinical research field

o Extensive experience in people management

o Good understanding and experience in the clinical trial process

o Strong knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations standard environment

o Understanding of the needs and use of data standards (CDISC, HL7) in the clinical trial environment

o Familiar with the application of SAS programming and related systems and software, excellent computer skills

and proficient in Microsoft Word, Excel and PowerPoint

o Focus on quality and detail

o Good communication skills and must be fluent in both written and spoken English or Japanese

o Good team player with excellent interpersonal and organizational skills

o High integrity in personality and professionalism

o Positive attitude, high degree of initiative, committed and able to work independently

o Self-initiative to perform duties, with good analytical and problem-solving capabilities

o Ability to handle multiple and varied tasks with enthusiasm, prioritize workload with attention to detail

o Meticulous and able to work in a fast-paced environment

o Able to work under pressure and under challenging timelines when required

o Ability to travel as required

上班地址：延安西路1326号生物大厦3楼