Senior Biostatistician

5 days ago

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

Moving Science Closer to Health

1001 - 5000

💰 $35.2M Venture Round on 2021-03

Description

• Provide statistical support for all phases of clinical development. • Specific responsibilities include reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs for tables, listings, figures and analysis datasets. • Include project work as a Lead Biostatistician and additionally mentoring and supporting junior team members. • Generate randomization schedules • Assist with statistical methods review of the clinical study protocol. • Provide and/or verify sample size calculations • 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 • Provide statistical support for supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests • Review output across programs to ensure consistency • Provide statistical analysis and reports to Data Monitoring Committees (DMCs) • Interact directly with study team and sponsors

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