北京招聘

·         Perform duties of a Trial Statistician to support complex clinical trials within national or international development projects or for marketed products as required.

·         Act as Project Statistician on indication-level or substance-level in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.

·         Develop definition and implementation of indication-level or compound-level database (including derived database), analysis and reporting standards.

·         Support management in resource planning and tracking for assigned trials and projects.

·         Assist the Head of statistics with the working of vendors, contractors in establishing procedures for programming and validating statistical analysis including writing the scope of work and preparing documents to be sent to the contract research organization (CRO). Act as a primary contact for vendors from a statistical perspective in a project.  Prepare specifications for data analyses by outside vendors as required. Assure compliance with the specifications by reviewing the vendors' products.

·         Ensure achievement of major statistical deliverables and milestones in coordination with other functions including Clinical Research, Safety, Statistical Programming, Data Management, Medical Writing and other functions.

·         Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analysis methods and implement innovative approaches at an indication or compound level.

·         Mentor junior statisticians.

·         Receive broad operating instructions in performing a majority of duties from manager and keeps manager abreast of programming status. Alerts management in case of resources issues, timelines problems or conflicts within the team.

岗位要求:

·         Ph.D. in statistics, biostatistics, or a related field; at least 4 years of experience in pharmaceutical clinical trial experience, preferably in the pharmaceutical industry and/or Regulatory Authorities, or M.S. in the above-mentioned areas with 7 years of similar experiences.

·         Ability to interact with authorities on statistical issues at the indication or compound level.

·         Thorough knowledge of study design and statistical analysis methodology,  drug development process and regulatory requirements.

·         Good knowledge of statistical programming languages (including SAS), software, techniques, and processes. Excellent oral and written communications skills.

·         Strong project management skills.

·         Evidence of strong teamwork in order to successfully work with a trial team and project level team members.

和铂医药是一家专注于肿瘤免疫领域创新药物研究与开发的全球化运营生物医药公司。公司将运用其拥有的全部自主知识产权的全人源单抗的转基因鼠系列核心技术平台，建立下一代治疗性肿瘤抗体药物产品管线,并将围绕Harbour的两大平台拓展合作与授权业务。公司总部及研发基地位于中国上海，另外在美国马塞诸塞州剑桥设立商业运营中心，在荷兰鹿特丹设立抗体研发平台创新中心，在波士顿地区设立了创新中心包括实验室和研发团队，也将在江苏昆山设立研发基地。公司拥有资深管理团队以及丰富的药物研究与开发经验。和铂医药要为满足中国及全球病人的需求而不断努力，依托拥有自主知识产权的核心技术平台,创建一个在肿瘤治疗领域有科学与技术领导力的国际性生物医药公司。同时, 在药物研发领域建立以技术平台为基础的对外合作，整合新的技术，推动中国整个抗体研发产业的进步。

Company Overview
Harbour BioMed is a global biotechnology company discovering and developing innovative therapeutics for cancer with a focus on immuno-oncology and autoimmunity/inflammation. The company's discovery and development programs are centered around its two patented transgenic mouse platforms for human antibody discovery.
The company is building its proprietary pipeline internally, through collaborations with co-development partners, as well as through selective preclinical and clinical stage asset acquisitions. Harbour BioMed also licenses the platforms to companies and academic institutions through its Harbour Antibodies subsidiary.
Harbour BioMed has headquarters and an R&D site in Shanghai, business operations in Cambridge, MA, and antibody platform development in Rotterdam, The Netherlands.
The company has an innovation center including research lab and a development team in Boston. Also, we are expanding to Kunshan site in Jiangsu for our R&D operation.