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
5 days ago
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
• Provide statistical support for all phases of clinical development. • Review statistical sections of protocols, writing statistical analysis plans, and developing SAS programs. • Lead Biostatistician and mentor 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, including development of table, figure and listing shells. • Validate analysis datasets, tables, figures, and listings 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. • 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 study team and sponsors. • Assist with completion of statistical activities for study within timelines. • Provide units for development of monthly project invoices. • Train and mentor new biostatisticians. • Assist with bid defense meetings.
• 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
Apply Now5 days ago
1001 - 5000
Senior Biostatistician providing statistical support for clinical development phases.
Join our Facebook group
👉 Remote Jobs Network