Clinical Trial Manager, Early Oncology
ICON plc
Google Cloud Platform
Principal Biostatistician, Medical Affairs
Syneos Health
full-time
Posted on:
Location: 🇨🇦 Canada
Visit company websiteJob Level
Lead
About the role
- Provide support to clinical study and/or project teams on all relevant statistical matters
- Provide input into study design, protocol development, setup and conduct to ensure data capture supports objectives and planned analyses
- Accountable for statistical deliverables: protocol sections, sample size calculation, randomization specifications, statistical methodology, SAP, data surveillance, statistical analysis results for CSR and appendices (TLGs and tables)
- Utilize external groups (e.g., CROs, DMCs) effectively
- Work with programming team on definitions, documentation, derived variables, and QC plans
- Perform or coordinate production of statistical analyses and review data distributions/properties
- Oversee execution of analyses per SAP, prepare statistical methods, and provide statistical insight for CSR and publications ensuring integrity and regulatory compliance
- Propose and perform exploratory and ad-hoc analyses relevant to study objectives
- Contribute to transparency and disclosure deliverables
- Plan and track study/project activities and timelines
- Ensure productive collaboration with other functions, promoting teamwork, quality, operational efficiency, and innovation
Requirements
- Previous experience leading medical affairs clinical studies is required
- PhD/MS in statistics or related discipline
- At least 5 years of pharmaceutical experience
- Good knowledge of pharmaceutical clinical development, including late phase and/or post-marketing activities
- Broad knowledge and good understanding of advanced statistical concepts and techniques
- Able to work in departmental computing environment and perform advanced statistical analyses using SAS and possibly other languages (e.g., R)
- Demonstrated strong interpersonal, communication, and writing skills
- Working experience in clinical development including interaction with external stakeholders
