5 days ago
• Provide statistical support for all phases of clinical development. • Review statistical sections of protocols, write statistical analysis plans, and develop SAS programs. • Includes project work as a Lead Biostatistician and mentoring junior team members. • Generate randomization schedules, verify sample size calculations, and assist with quality control for SAS programs. • Provide statistical analysis and reports to Data Monitoring Committees as the unblinded statistician.
• 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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