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, and develop SAS programs. • 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 to support the analysis of clinical trials data using SAS. • Assist with quality control for statistical based SAS programs and other study documents (e.g., presentations and reports). • Provide statistical support for supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests. • Assist with statistical consulting tasks. • Review output across programs to ensure consistency. • Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded statistician. • 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. • Interact directly with 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.

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 • Understanding of advanced clinical trial design concepts, such as non-inferiority, adaptive methods, type-I error protection, dynamic randomization, and sample size estimation in complex settings • Understanding of advanced statistical methodologies applicable to clinical trials, such as survival analysis, stratified or covariate analyses, sequential methods, and strategies for handling missing data • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines • Excellent communication and interpersonal skills to effectively interface with others • Excellent problem solving skills • Excellent presentation skills