Senior Biostatistician
5 days ago
Description
• Provide statistical support for all phases of clinical development • Review statistical sections of protocols • Write statistical analysis plans • Develop SAS programs for tables, listings, figures and analysis datasets • 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 • 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 on statistics-related project components • Interact directly with study team and sponsors • Train and mentor new biostatisticians • Assist with bid defense meetings • Additional responsibilities for Senior and Principal levels
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 • Experience with Oncology desirable • Knowledge and experience of CDISC data structures
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