Biostatistics Services
Statistical Analysis: Our statisticians specialize in analysis appropriate for clinical and public health research, including but not limited to:
- Statistical modeling: generalized linear models, time to event modeling, longitudinal and hierarchical modeling
- Complex sample analysis of large databases: Healthcare Cost and Utilization Project (HCUP), National Health and Nutrition Examination Survey (NHANES), National Cancer Database (NCDB), others
- Multivariate techniques
- Survey tool development and validation
- Analysis of epidemiologic studies
- Meta-analysis
- Analysis of clinical trials
Your statistician will provide a written summary of methods and results in addition to tables and figures, and will assist you in manuscript preparation and responses to peer review as appropriate.
Study Design, Protocol and Grant Preparation: Our statisticians can recommend study design options and provide power analysis, statistical analysis plan, and a letter of support for protocols and grants. In consultation with the Biostatistics Director and Medical Director, you may additionally hire a statistician to join your research team at an agreed-upon percent effort.
Data Collection and Monitoring: It is our goal to forestall data entry errors and ensure a smooth transition from data capture to analysis. We provide data management services commensurate with 21 CFR Part 11 federal guidelines. The Biostatistics Core offers training and database development support for REDCap¹ (https://projectredcap.org/). Most clinical research studies use our internal REDCap site for data collection. Databases that feature collection of protected health information, such as retrospective chart reviews and prospective trial case report forms, should be created and maintained on this internal site. The external REDCap site may only be used for specific project types, which include: multi-center studies, projects that require external participants to complete surveys, or studies that require e-Consent. The principal investigator for the study must complete an External REDCap Request Form and receive approval for access. More information about REDCap at Loyola can be found on the Research Computing Services REDCap page.
Safety Reviews: Study investigators, the study medical monitor, and a Biostatistician should discuss and plan interim analyses for studies that may pose a significant or unknown safety risk to participants. We encourage you to request a Biostatistician to prepare an interim analysis plan that addresses individual stopping criteria as well as trial stopping criteria before data collection begins.
Clinicaltrials.gov: To comply with federal law, results must be uploaded in a timely manner for all trials registered on clinicaltrials.gov. You may request a statistician to assist you with reporting your results to clinicaltrials.gov
Seminars and Lectures: We provide several lectures to the Stritch School of Medicine and surrounding community throughout the year. These lectures are typically 60 minutes in length and can cover a variety of topics, including but not limited to: statistical methods in medical literature, power and sample size calculations, database design, clinical trials design, test development and evaluation, and statistical computing.
1Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde, Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81.
Statistical Analysis: Our statisticians specialize in analysis appropriate for clinical and public health research, including but not limited to:
- Statistical modeling: generalized linear models, time to event modeling, longitudinal and hierarchical modeling
- Complex sample analysis of large databases: Healthcare Cost and Utilization Project (HCUP), National Health and Nutrition Examination Survey (NHANES), National Cancer Database (NCDB), others
- Multivariate techniques
- Survey tool development and validation
- Analysis of epidemiologic studies
- Meta-analysis
- Analysis of clinical trials
Your statistician will provide a written summary of methods and results in addition to tables and figures, and will assist you in manuscript preparation and responses to peer review as appropriate.
Study Design, Protocol and Grant Preparation: Our statisticians can recommend study design options and provide power analysis, statistical analysis plan, and a letter of support for protocols and grants. In consultation with the Biostatistics Director and Medical Director, you may additionally hire a statistician to join your research team at an agreed-upon percent effort.
Data Collection and Monitoring: It is our goal to forestall data entry errors and ensure a smooth transition from data capture to analysis. We provide data management services commensurate with 21 CFR Part 11 federal guidelines. The Biostatistics Core offers training and database development support for REDCap¹ (https://projectredcap.org/). Most clinical research studies use our internal REDCap site for data collection. Databases that feature collection of protected health information, such as retrospective chart reviews and prospective trial case report forms, should be created and maintained on this internal site. The external REDCap site may only be used for specific project types, which include: multi-center studies, projects that require external participants to complete surveys, or studies that require e-Consent. The principal investigator for the study must complete an External REDCap Request Form and receive approval for access. More information about REDCap at Loyola can be found on the Research Computing Services REDCap page.
Safety Reviews: Study investigators, the study medical monitor, and a Biostatistician should discuss and plan interim analyses for studies that may pose a significant or unknown safety risk to participants. We encourage you to request a Biostatistician to prepare an interim analysis plan that addresses individual stopping criteria as well as trial stopping criteria before data collection begins.
Clinicaltrials.gov: To comply with federal law, results must be uploaded in a timely manner for all trials registered on clinicaltrials.gov. You may request a statistician to assist you with reporting your results to clinicaltrials.gov
Seminars and Lectures: We provide several lectures to the Stritch School of Medicine and surrounding community throughout the year. These lectures are typically 60 minutes in length and can cover a variety of topics, including but not limited to: statistical methods in medical literature, power and sample size calculations, database design, clinical trials design, test development and evaluation, and statistical computing.
1Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde, Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81.