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Responsibilities
- Generate randomization schedules
- Assist with statistical methods review of the clinical study protocol
- Provide and/or verify sample size calculations
- Provide input into development of case report forms (CRFs)
- Author statistical analysis plans, including table, figure, and listing shells
- Validate analysis datasets, tables, figures, and listings using SAS
- Assist with quality control for SAS programs and other study documents
- Provide statistical support for supplemental or exploratory analyses
- Assist with statistical consulting tasks
- Review output across programs to ensure consistency
- Provide statistical analysis and reports to Data Monitoring Committees (DMCs)
- Review statistical sections of clinical study reports
- Work directly with sponsors, project managers, and external vendors
- Interact directly with study team and sponsors
- Assist with completion of statistical activities for study within timelines
- Provide units for development of monthly project invoices
- Train and mentor new biostatisticians
- Assist with bid defense meetings
Requirements
- Master’s degree / PhD in Statistics, Biostatistics, or related field with strong experience
- At least 7 to 10 years experience as a Biostatistician in a Clinical Research Organisation
- Demonstrates extensive knowledge with industry standards, such as ICH guidelines and FDA guidelines
- Experience with SAS
- Familiarity with complex statistical methods for Phase I-IV clinical trials
- Experience with Oncology desirable
- Knowledge and experience of CDISC data structures
Benefits
- Remote work option in Poland, Hungary, Serbia, Romania, or Slovakia
