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

•To 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. •Role includes project work as a Lead Biostatistician and additionally mentoring more junior team members. •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. •Validate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data. •Assist with quality control for statistical based SAS programs and other study documents.

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