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Job Specifications
Job Title: Principal Statistician
Department: Statistics and Pharmacokinetics
Location: Shanghai or Beijing
The statements below reflect the general responsibilities and requirements
of the identified position but may not describe all the work requirements
that may be inherent in the job.
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 Covance staff 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 as one of Covance
signatories.
• 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 Covance 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 4 years’ postgraduate experience in the application of
statistics to clinical trials. |
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