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. • Review statistical sections of protocols. • Write statistical analysis plans. • Develop SAS programs for tables, listings, figures and analysis datasets. • 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. • Assist with quality control for statistical based SAS programs and other study documents. • Provide statistical support for supplemental or exploratory analyses for regulatory agencies. • Train and mentor new biostatisticians. • Work directly with sponsors, project managers, and external vendors on statistics-related project components.

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