5 days ago
• 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. • Include project work as a Lead Biostatistician. • Mentor and support junior team members.
• 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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