Dynamic team-oriented manager with expertise in performance management and team leadership. Proven track record of optimizing staff utilization and delivering high-quality statistical analysis to meet project goals. Background in clinical research across multiple therapeutic areas and study phases. Extensive background in statistical programming and data management.
Overview
41
41
years of professional experience
Work History
Manager, Statistical Programming
ICON PLC
Blue Bell, PA
12.2018 - Current
Ensure department and study level goals and objectives are consistently met to the highest standard of quality.
Ensure team deliverables consistently meet study timelines, quality standards and contractual requirements.
Implement effective tracking and reporting to monitor staff workload and optimize staff utilization.
Provide technical and managerial leadership, including mentorship and training of direct reports.
Delegate responsibilities appropriately with the target of continuously developing team capabilities.
Principal Clinical/Statistical Programmer
ICON, Formerly PRA Health Sciences
Charlottesville, VA
11.2012 - 12.2018
Developed databases for study data collection in adherence to study protocols and planned data analysis.
Collaborated with cross-functional teams to ensure data quality by documenting and programming data quality checks - identifying data inconsistencies and supporting data cleaning activities.
Created detailed programming specifications for complex datasets leveraging SAS programming language.
Contributed to successful clinical trial outcomes by delivering accurate and timely statistical analysis.
Conducted quality control checks on datasets and analysis outputs, ensuring high accuracy in reporting results to stakeholders.
Conducted in-depth exploratory data analyses to identify trends and patterns, informing business decisions.
Mentored junior programmers, facilitating knowledge transfer and enhancing team capabilities.
Clinical Data Coordinator
ICON, Formerly PRA Health Sciences
Charlottesville, VA
06.1985 - 03.1995
Developed and maintained clinical trial databases to ensure data integrity and compliance with regulatory standards.
Reviewed clinical data for accuracy, consistency, and completeness in alignment with study protocols and guidelines.
Streamlined data entry workflows, significantly reducing turnaround times for data validation processes.
Provided strategic input on process improvements that enhanced the quality of clinical trial deliverables.
Resolved data discrepancies through meticulous investigation and collaboration with relevant departments.
Conducted regular audits on clinical trial databases to identify potential issues and implement necessary corrective actions.
Facilitated clear communication between stakeholders through concise status updates and informative progress reports.
Supported the preparation of final study reports, utilizing expert knowledge of dataset structures and content.
Continually sought opportunities for professional growth, staying current with industry trends and best practices in clinical data management.
Supported statistical analysis efforts by providing clean, accurate, and complete data for interpretation.
Developed comprehensive training materials for new hires, increasing overall team proficiency.
Participated in quality assurance reviews to verify accuracy and reliability of data.
Enforced strict data validation rules to maintain accuracy and completeness of clinical data.
Upheld critical security standards when managing user access actions such as setting up and removing accounts.
Education
No Degree - Computer Science
Blue Ridge Community College
Weyers Cave
12.1990
Skills
Team leadership
Staff management
Resource allocation, time management, work prioritization
Associate Manager, Statistical Programming at Parexel International India Pvt LtdAssociate Manager, Statistical Programming at Parexel International India Pvt Ltd