Precision Medicine Group is hiring a
Principal Biostatistician

Summary

Join Precision Medicine Group as Principal Biostatistician to provide statistical support for all phases of clinical development. The role involves writing and reviewing statistical sections of protocols, conducting statistical analyses, and presenting results to project teams and sponsors.

Requirements

• Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years experience
• Experience with SAS
• Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines

Responsibilities

• Generate and/or verify randomization schedules
• Develop and review statistical methods of the clinical study protocol including complex study designs
• Provide and/or verify sample size calculations. Perform or assist with advanced calculations including adaptive design
• Provide input into development of case report forms (CRFs)
• Author statistical analysis plans, including development of table, figure and listing shells, complex study design and late phase
• 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 or supervise programming and statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
• Ability to serve as a biostatistical consultant to company staff globally, with understanding of varying regional perspectives
• 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[1]related project components
• Interact directly with study team
• Interact directly with sponsors
• Lead all statistical activities for study within timelines
• Independently perform budget health review on projects and review monthly invoices
• Perform oversight responsibilities on projects for other 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
• Broad experience with late phase and/or submissions
• Experience in consulting with clients on study design
• Superior understanding of a specific therapeutic area and/or statistical methodology (eg, adaptive design, missing data

Benefits

• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation