The Biostatistics and Data Management Core (BDMC) at The Children's Hospital of Philadelphia (CHOP) supports investigators from virtually all subspecialties of pediatric medicine and supports studies ranging from small, narrowly defined basic science projects to large, multi-site clinical trials.
BDMC can assist you in designing experiments, planning of clinical protocols, analyzing and interpreting data, and presenting and disseminating results. And the data management team members have expertise in designing case report forms, developing databases, creating data management plans, developing metrics to report on study progress, and delivering high-quality datasets for analysis. The BDMC offers the unique advantage of experience with Biologics License Application submissions.
The Biostatistics and Data Management Core currently supports more than 50 funded studies and collaborates with investigators on numerous grant applications each year. The BDMC is staffed by a Scientific Director, Deputy Director, and data management/information technology managers, as well as approximately 20 additional staff members representing the disciplines of biostatistics, data management, information technology and administration. The BDMC is located on the CHOP campus (3535 Market Street), and is operated and supported by Westat, a large health research organization with extensive biostatistics, data management and information technology capabilities.
Role: Project Administrator, The CHOP Biostatistics and Data Management Core
"The biostatistics subcore offers the following services:
• Study Design (from pre-clinical, basic science to multi-site clinical trials and observational studies)
• Sample size and Power Calculations
• Statistical Analysis (planning, data analysis and report writing)
• Statistical Analysis for Data and Safety Monitoring Boards (DSMB)
• Statistical Support for Grant Applications
• Statistical Support for Abstracts and Manuscripts
• Statistical Methodological Research
• Free Statistical Consulting"
"The data management/information technology subcore provides a selection of services including case report form development, single or double data entry, data review, discrepancy checking and resolution, and quality assurance audits. Data management software and activities are conducted according to standard operating procedures
The level of involvement ranges from consultation through full-service data management. The data management/information technology subcore offers the following services:
• Database Development and Maintenance using Oracle, REDCap, SQL Server and other database tools
• Web-based Systems for data capture and study operations
• Case Report Form (CRF) Design (paper and electronic)
• Data Entry (single or double data entry) and Document Imaging
• Data Review, including query generation and resolution
• Audits to ensure accuracy and quality of study data
• Creation of Analytic Datasets (e.g., SAS and SPSS)
• Data management systems and documentation that meet regulatory requirements (e.g., FDA, Part 11)"
"Collaborate with investigators to develop study design. Write statistical analysis section (including power and sample size calculations), and data collection, database development and management procedures."
"Perform limited statistical analyses of existing datasets (cost estimates provided if additional analyses are needed)."
"Provide options and guidance for conducting statistical analyses and developing database management systems using tools such as REDCap."