Senior Biostatistician

Summary

Join Precision Medicine Group as a Senior Biostatistician to provide statistical support for all phases of clinical development. The ideal candidate will have a Master's degree or equivalent in Statistics, Biostatistics, or related field with 4+ years experience; PhD degree in Statistics, Biostatistics, or related field with 2+ years experience.

Requirements

• Master's degree or equivalent in Statistics, Biostatistics, or related field with 4+ years experience; PhD degree in Statistics, Biostatistics, or related field with 2+ years experience
• Experience with SAS
• Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
• Knowledge of advanced clinical trial design concepts and advanced statistical methodologies

Responsibilities

• Generate and/or verify randomization schedules
• Review statistical methods 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
• Review statistical analysis plans written by other biostatisticians
• Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS
• Perform quality control for statistical based SAS programs and other study documents (e.g., presentations and reports)
• Provide programming and statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
• Perform statistical consulting tasks with some senior oversight
• Review output across programs to ensure consistency
• Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded biostatistician
• 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
• Lead all statistical activities for study within timelines
• Assist with budget health review on projects and review monthly invoices
• Perform oversight responsibilities on projects for new biostatisticians
• Assist with budget development and present at bid defense meetings
• Participate in the development and maintenance of departmental procedures and standards (templates, SOPs, WIs etc.)
• Review study tasks to ensure study being conducted in line with agreed budget; identify change in scope

Preferred Qualifications

• Experience with Oncology and rare diseases
• Experience with late phase and/or submissions
• Experience in consulting with clients on study design