KCR
Clinical Monitoring • Functional Service Provider • Site Set up and Contracting • Late Phase • Medical & Regulatory Affairs
Principal Biostatistician
December 7
KCR
Clinical Monitoring • Functional Service Provider • Site Set up and Contracting • Late Phase • Medical & Regulatory Affairs
Description
• Ability to perform Study Statistician role with minimal supervision • Demonstrates strong statistical expertise with a good understanding of more complex design of experiments and inference methodologies (where applicable awareness / knowledge of Bayesian, Futility & Predictive Inference, Estimands, Missing Data etc.) • Where required, ability to actively participate in matrix team meetings • Applies standard processes to tasks, ensuring that deliverables are accurate, high quality and met according to agreed timelines • Extensive working knowledge of GxP, ICH, and external regulations (as applicable) • Quality Control (QC) of other people's work under supervision • Under supervision: Supports design, analysis and interpretation, uses a wide range of statistical approaches and/or applicable software to explore options • Authors analysis plans and prepares statistical inputs to key documents and presentation materials • Contributes to the development of statistical strategy at a study-level, which may be shared with stakeholders
Requirements
• Master’s degree in statistics or biostatistics required • Minimum of 8 years of biostatistical experience desired • Clinical experience is mandatory • Exhibit expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices. • Thorough knowledge of and experience with CDISC standards is desired • Demonstrate ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials • Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study • Auto-immune and/or oncology clinical study background is a plus • Experience in managing vendors is a plus
Benefits
• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being • Life assurance • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
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