Experience
Accomplished and detail-oriented professional with extensive experience in the CRO industry, specializing in resource allocation and utilization for global projects across diverse therapeutic areas. Track record of leading North America resourcing team, conducting weekly meetings and providing valuable coaching and mentorship. Active involvement in Global Resourcing meetings with various regions hones the ability to consult with project leads, managers, and leaders on resourcing needs, budgets, requirements, and risks. Expert at overseeing production and quality control of analysis datasets, tables, listings, and figures for both internal and external clients. Proficient in CDISC SDTM and ADaM standards with unwavering goal to deliver high-quality and punctual results consistent with client expectations in adherence to rigorous regulatory standards. Demonstrated success in extending contribution beyond project work by actively engaging in internal training programs on CDISC SDTM and playing a pivotal role in client presentations and bid defenses. Areas of Expertise • Resource Management • Diverse Team Leadership • Strategic Planning & Execution • Statistical Programming • Project Management • Effective Communication • Complex Issues Resolution • Client Relations Management • Risk Mitigation & Control • Quality Assurance • Budget Management • Regulatory Compliance • Data Management & Analytics • Process Improvement • Cross-Functional Collaboration Career Experience Iqvia, Inc. (formerly Quintiles, Inc.) 2017 – 2023 Resource Manager / Associate Statistical Programming Director Managed various functions, including leading teams, delivering feedback, and offering mentorship. Delegated resources to both new and ongoing projects, considering factors such as needs, budgets, requirements, and expertise levels, with a keen focus on ensuring project teams' stability and equilibrium. Provided consultation to project leads for facilitating the next lead assignment, to managers for aligning resource assignments with staff development priorities, and to leaders on risk management, conflict resolution, and escalations. Conducted regular assessments of weekly allocation reports to guarantee data accuracy and took necessary measures to rectify instances of resource overutilization and underutilization. • Headed weekly resourcing meetings and actively participated in Global Resourcing gatherings spanning India, South Africa, Europe, China, and Japan. • Established comprehensive customer case history by maintaining meticulous project tracking and resource allocation. • Actively chaired and directed Project Review Meetings to remain abreast of project progress and resource requirements. • Collaborated closely with project teams to optimize the allocation of resources. Iqvia, Inc. (formerly Quintiles, Inc.) 2012 – 2017 Senior Statistical Programming Scientist Spearheaded and managed coordination of statistical programming activities across multiple clinical trials. Led development and documentation of SAS programs for the creation of SDTM and ADaM datasets. Produced crucial tables, listings, figures, define.xml files, and reviewer's guides essential for comprehensive clinical trial reports and submissions. Cultivated strong collaboration with data management, biostatistics, and diverse departments to ensure the punctual completion of statistical programming tasks. Actively participated in client presentations and played a vital role in bid defenses. • Provided pivotal support for validation, implementation, and ongoing maintenance of statistical programming processes. • Actively engaged in cross-functional team meetings, fostering discussions on project timelines and key milestones. • Conducted internal training sessions on CDISC SDTM for the Biostatistics & Data Management departments, while simultaneously serving as the department's CDISC Subject Matter Expert (SME) and Technical Point of Contact. • Assumed the role of mentor to the entire programming team, delivering comprehensive training and guidance to uphold the quality and consistency of programming output. Iqvia, Inc. (formerly Quintiles, Inc.) 2007 – 2012 Statistical Programming Scientist Executed, devised, and coordinated the multiple activities for various studies as lead programmer. Developed analysis datasets and facilitated seamless data transfers for both internal and external clients. Generated essential tables, listings, and figures. Implemented quality control checks for source data and periodically reported data issues. Managed project budgets and allocated resources effectively, including a thorough understanding Scope of Work (SOW), oversight of Out of Scope (OOS) activities, and precise resource forecasting. Delivered materials for Data Monitoring Committee (DMC) and Data Safety Monitoring Board (DSMB) meetings in a timely manner, along with final database lock deliveries, ensuring strict compliance with regulatory submissions. • Provided comprehensive mentoring and guidance to all programming staff, ensuring the quality and consistency of programming output. • Generated and maintained documentation for all statistical programs. • Liaised with global initiative teams within the Biostatistics department. Additional Experience Analyst/Senior Analyst, Iqvia, Inc. (formerly Quintiles, Inc.) Statistical Programmer I/Statistical Programmer II, Iqvia, Inc. (formerly Quintiles, Inc.) Statistical Programmer, Program Resources, Inc Statistical Research Assistant, North Carolina Department of Public Instruction