Precision Medicine Group is hiring a
Senior/Principal Biostatistician

Summary

Join Precision for Medicine as an experienced Senior Biostatistician/Principal Biostatistician to work remotely in UK, Spain, Poland, Hungary, Serbia, Romania or Slovakia. Provide statistical support for all phases of clinical development, including reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs.

Requirements

• Master's degree / PhD or equivalent in Statistics, Biostatistics, or related field with strong relevant experience
• At least 7 to 10 years experience working as a Biostatistician for a Clinical Research Organisation
• Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, 21 CFR Part 11, and FDA guidelines
• Experience with SAS
• Familiarity with complex statistical methods that apply to Phase I-IV clinical trials

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 development of table, figure and listing shells
• Validate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS
• Assist with quality control for statistical based SAS programs and other study documents (e.g., presentations and reports)
• Provide statistical support for supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
• Assist with statistical consulting tasks
• Review output across programs to ensure consistency
• Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded statistician
• Review statistical sections of clinical study reports
• Work directly with sponsors, project managers, and external vendors on statistics-related project components
• Interact directly with study team
• Interact directly with 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

Preferred Qualifications

• Experience with Oncology desirable
• Knowledge and experience of CDISC data structures