发帖
雷达卡
We are looking for "Princial Statistician", the following is the JD. The working place is ：Beijing. Please contact me xju_ql@sina.com if you are interested in this position.
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I. Job Summary:
A. Duties and Responsibilities:
¨ Supervision of less-experienced statisticians within project activities¨ Statistical/Biometrics lead for large global or other major programs.¨ Provide statistical input into other disciplines’ activities and participate in interdepartmental processes.¨ Provision of technical solutions and advice to colleagues and to clients on statistical methodology and principles.
¨ Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data–handling rules and mockups.
¨ Responsible for Biostatistics’ deliverables within assigned projects.
¨ Develop and coordinate QC procedures for Biometrics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within a specific project.
¨ Statistical analysis of clinical trial data and related decision making.
¨ Responsible for statistical input to statistical reports and Clinical Study Reports. Authorizes final reports
¨ Provide statistical guidance in development of clinical research program and in design of individual studies as part of multi-disciplinary team; responsible for statistical input to protocol; approves protocol as signatory.
¨ Provide statistical input into design/review of format of CRFs.
¨ Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule). Provide input into planning activities related to the preparation of, distribution of and access to randomization and unblinding information.
¨ Independent peer review of statistical deliverables, eg, protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reports.
¨ SAS programming and related activities for the presentation and analysis of clinical trial data.
¨ Contribution to review and amendment of departmental processes and supporting documentation.
¨ Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.
¨ Provide support for special committees, eg, DMCs, including input/review of charters, and ensuring maintenance of appropriate blinding.
¨ Contribute to proposal activities and client presentations.
¨ Represent the department during audits.
¨ Carry out all activities according to appropriate SOPs, working within the framework of the Quality Management System and to GCP.
¨ Perform other duties as requested by management.
B. Language Skills Required:
¨ Speaking: Yes English/Mandarin if located in China
¨ Writing/Reading: Yes English/Mandarin if located in China
II. Education/Qualifications:
Required:
An MSc or PhD in a statistics subject, preferably with a strong medical statistics component.
(Alternative academic qualifications are assessed for comparability.)
III. Experience:
Required:
Approximately 5.5 years’ postgraduate experience in the application of statistics to clinical trials.
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