Biostatistics

Flexible support, unwavering industry expertise

Experis Solutions has biostatistical professionals with decades of industry experience. Their knowledge and experience in the ever-changing regulatory environment and various therapeutic areas enables them to add value by applying the appropriate statistical strategies that ensure clear, complete and accurate planning, analysis, interpretation and reporting.

Project Support

Experis Solutions biostatisticians collaborate with project teams on all phases of drug development to ensure consistent implementation of standards, resulting in high-quality output. Part of this collaboration involves development of a concise and accurate Statistical Analysis Plan (SAP) that provides:

• A clear definition of study objectives and target populations
• Detailed description of primary, secondary and other study endpoints, statistical methodology, and associated analysis populations
• Sample size rationale and power analysis
• Conventions for handling incomplete data, including sensitivity analyses
• Mock-ups/shells of all planned tables, listings and figures

Analysis and Reporting

Our seasoned biostatisticians have broad experience in analysis and reporting covering:

• PK/PD models
• Time to event analyses
• Mixed models including analysis of variance and covariance
• Nonlinear modeling
• Categorical data analyses
• Repeated measures
• Regression modeling including logistic regression
• Non-parametric methods
• Dose-response modeling

Statistical Consultation

Proper development of a clinical program and design of a study are critical to a product’s success. Our experienced team provides statistical consultation throughout the life of a project, including:

• Consultation on development of program plans as well as individual study design, consistent with ICH guidelines
• Development of randomization schemes and production of randomization schedules to preserve the integrity of treatment masking
• Statistical consultation and guidance during the study
• Scientific collaboration on ad hoc analyses, regulatory interactions, regulatory filings, and annual safety reporting
• Statistical verification of key study results
• Co-authorship of clinical study reports
• Interim analyses
• Data safety monitoring
• Real-time and exploratory analyses
• Formal presentation of trial results to senior client executives
• Support for the development of abstracts and manuscripts
• Statistical training