北京招聘

Key accountabilities

All activities must be conducted in accordance with project specific documentation, applicable SOPs, ICH GCP and applicable regulatory requirements.

Maintain effective professional relationships with external customers, and with the internal project team.

The focus of this role will be to contribute statistical expertise at all levels of drug/device development, and undertake design and analysis of clinical studies as well as meta-analysis in accordance with applicable regulatory guidelines, using validated systems and programs.

• Assume the role of Study Statistician for assigned studies and independently manage all statistical aspects of a project

• Leads activities to identify new business opportunities for Statistical services

• Preparation and review of Statistical Analysis Plans and Statistical Contributions, with appropriate guidance from other statistical staff.

• Statistical analysis of clinical trial data using basic methodology, with appropriate guidance from other statistical staff.

• Production of data tables and graphs to the required specification for clinical, pharmacokinetic and statistics reports.

• Preparation of randomization specifications and the generation of randomization schedules.

• May review the format of CRFs under the direction of senior Statistical staff.

• Perform sample size calculations as required.

• Provide statistical support to SAS Programmers.

• SAS programming and related activities for the presentation and analysis of clinical trial data.

• Review of protocols, providing a statistical advice service for internal and external clients.

• Scheduling of clinical statistical work to meet required deadlines. Ensuring that projects are completed in a timely and accurate manner.

• Liaison with internal and external clients, as required, with regards to the requirements for analysis, tables and graphs.

• Review of Clinical Study Reports.

• Perform peer review of other Statisticians’ work.

• Perform QC of analysis datasets, data displays for secondary efficacy and safety variables.

• Training of other members of staff within the department in statistical methods and programming techniques.

• Assist Business Development in forecasting Statistic resource needs for new study bids

Skills, Knowledge and Experience

• Masters, or higher qualifications in Statistics

• Minimum 5+ years’ experience as a Statistician in CRO or Pharma

• Excellent working knowledge of SAS software

• Working knowledge of relevant Data Standards (such as CDISC / ADaM)

• Experience managing projects.

• Experience in team coordination.

• Working knowledge of regulatory requirements for clinical trials and medical research.

• Strong focus on quality and timely delivery of work.

• Well organized with good time management skills.

• Strong problem solving and analytical skills.

• Excellent interpersonal skills with high level of proficiency in English

• Ability to work well and flexibly i.e. autonomously, in small teams and with a wide range of varying stakeholders.

• Ability to see the big picture, whilst still maintaining a focus on detail and implementation

• Strong leadership and mentoring skills

The George Institute China is a medical research institute, and a wholly-owned foreign enterprise, that was established as an affiliated partner with Peking University Health Science Centre in March 2007, whose registered name is Beijing George Medical Research Co. Ltd. The aim of the Institute is to promote high quality medical research through the conduct of randomised controlled trials and epidemiological studies with various government and non-government partners for the purpose of providing evidence-based approaches to improve the health of Chinese people.
George Clinical is the clinical research delivery arm of the George Institute and manages phase I to phase IV clinical studies for both commercial and medical research organisations. George Clinical is recognized as a leading Clinical Research Organisation (CRO) bringing together medical and scientific expertise in the clinical trials area. George Clinical China is a wholly owned foreign enterprise and trades under the name George (Beijing) Clinical Research Co. Ltd.