Senior Biostatistician
Taiwan, Remote求人ID R0000032433 Category Biostatistics Jobs
About this Role
Key Accountabilities:
Operational Execution:
· Coordinate and lead a project team to successful completion of a project within timelines and budget
· Interact with clients as key contact with regard to statistical and contractual issues
· Perform QC of derived datasets, tables, figures and data listings produced by other members of the department
· Check own work in an ongoing way to ensure first time quality
· Understand and apply advanced statistical methods
· Lead production and quality control of randomizations, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
· Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review
· Travel to, attend and actively contribute to all kind of client meetings as appropriate (eg discussing analysis concepts, presenting, discussing and interpreting study results)
Business Development:
General Activities:
• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
• Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.
• Proactively participate in and/or lead process/quality improvement initiatives.
• Provide consultancy to internal and external sponsors with regard to statistical programming tasks.
• Represent PAREXEL at sponsor marketing and technical meetings.
• Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).
Skills:
· Good analytical skills
· Good project management skills
· Professional attitude
· Attention to detail
· Thorough understanding of statistical issues in clinical trials
· Prior experience with SAS programming required
· Ability to work independently
· Good leadership skills
· Good business awareness/ business development
· Willingness to work in a matrix environment and to value the importance of teamwork
• Demonstrate commitment to refine quality processes.
Knowledge and Experience:
· PhD in Statistics or related discipline with some experience or MS in Statistics or related discipline with significant experience
· The knowledge of pharmacokinetic data is an advantage
· Competent in written and oral English in addition to local language
Education:
· PhD in Statistics or related discipline, MS in Statistics or related discipline
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