Senior Biostatistician

5 days ago

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pfm medical, inc.

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pfm medical, Inc. is a subsidiary of pfm medical ag (Cologne, Germany) and was established in 2001 to serve as headquarters for North, Central, and South American development, manufacturing, marketing, and distribution activities$1. .$1

Medical Device Manufacturing

11 - 50

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. • Generate randomization schedules. • Assist with statistical methods review of the clinical study protocol. • Provide and/or verify sample size calculations. • Provide input into the 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 using SAS. • Assist with quality control for statistical-based SAS programs. • Provide statistical support for supplemental or exploratory analyses for regulatory agencies. • Assist with statistical consulting tasks. • Review output across programs to ensure consistency. • Provide statistical analysis and reports to Data Monitoring Committees (DMCs). • Review statistical sections of clinical study reports. • Work directly with sponsors, project managers, and external vendors on statistics-related project components. • Interact directly with the study team and sponsors. • Train and mentor new biostatisticians.

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