Covance

Principal Biostatistician (全国)

Job Location(s) CN-Shanghai
Job Number
2021-70416
Job Category
Biostatistics/Programming
Position Type
Full-Time
Telecommute
Yes

Job Overview

- Biostatistics lead for large global or other major projects.
- 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.
- Supervision of less-experienced biostatisticians within project activities.
- Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
- Training and development of less-experienced staff within the department
- 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 Biostatistics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within 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.
- Determine documentation requirements for Biostatistics aspects of projects. Give guidance to support business and regulatory requirements including definition of appropriate documentation, storage/communication media, and retention/return of documents at study close-out.
- Independent peer review of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reprots.
- SAS programming and related activities for the presentation and analysis of clinical trial data.
- Contribute 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, e.g., DMCs, including input/review of charters and ensuring maintenance of appropriate blinding.
- Contact with client across multiple disciplines.
- 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.

Education/Qualifications

- 8+ years of experience or an equivalent combination of education or experience to successfully perform the key responsibilities of the job
- Ability to program in one or more statisticial software packages (SAS) used to conduct statistical analyses. SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
- Ability to effecitively communicate statistical concepts
- A good knowledge of the overall clinical trial process
- Experience in the preparation of Statistical Analyais Plans, analysis, reporting, etc.

Experience

- Master’s degree, equivalent, or higher in Biostatistics or related field

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