Principal Biostatistician

Responsibilities

• Resolve complex issues using professional concepts and company objectives.
• Contribute to study design considerations in internal and client meetings.
• Provide and discuss sample size scenarios.
• Oversee production and quality control of randomization schedules, statistical analysis plans, statistical reports, and process supporting documents.
• Design statistical analysis plans and table shells in accordance with study protocols or for NDA submissions.
• Develop SAS programs to produce and/or QC statistical tables/figures/data listings.
• Develop SAS programs to produce and validate analysis datasets.
• Maintain expertise in state-of-the-art statistical analyses.
• Review and/or write the statistical and results sections of clinical study reports.
• Train and guide junior level and new staff.
• Understand regulatory requirements related to specific therapeutic areas.
• Support proposal development and bid defense meetings.
• Manage project budget and forecast resources needed for studies.

Requirements

• MS in Biostatistics, Mathematics, Statistics, Public Health or related discipline required.
• PhD in Biostatistics, Mathematics, Statistics, Public Health or related discipline preferred.
• Knowledge of SAS statistical computing package is a must.
• Knowledge of other database management and statistical software packages is a plus.
• 10+ years of experience in statistical analysis of clinical trials data.

Skills

• Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods.
• Proficiency in SAS statistical programming.
• Knowledge of other statistical and data management software packages is a plus.
• Strong written and oral communication skills.
• Strong project management and mentoring/leadership skills.
• In-depth knowledge of applicable clinical research regulatory requirements; e.g., GCP and ICH guidelines.
• Ability to effectively manage multiple tasks and projects.
• Ability to clearly describe statistical techniques and interpret results.

Education

MS in Biostatistics, Mathematics, Statistics, Public Health or related discipline required.

PhD in Biostatistics, Mathematics, Statistics, Public Health or related discipline preferred.

Pay

The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position.