Clinical Data Management & Trial Design Expert
Resume:
Amro Ali
******.****@*****.***
Local/Available Immediately
Skill Matrix:
Skill
Years of Experience
Clinical Data Management
10+ Years
CRF Design
8+ Years
EDC Tools (REDCap)
8 Years
Risk Identification & Mitigation
8+ Years
Project Management
7+ Years
Multi-Trial Oversight
8+ Years
Education:
Master of Public Health– Epidemiology
Walden University School of Public Health, Minneapolis, MN – 2020.
Bachelor of Science– Healthcare Management
Texas University at Dallas, Dallas, TX – 2015.
Associate of Science
Richland College, Dallas, TX, United States-2009.
Experience Overview:
Expertise in study design, trial conduct, data analysis, and clinical study report (CSR) in oncology, Immunology, central nervous system (CNS) disease, cardiovascular disease, & Type 2 diabetes.
Drove and implemented novel methods and innovative trial designs. Phase 1 dose-finding trials using 3+3 design, Bayesian Optimal Interval (BOIN) designs, and Bayesian Logistic Regression Model (BLRM) method with escalation with overdose control (EWOC) principle to investigate maximum tolerated dose (MTD) and dose-toxicity relationship.
Phase 2 dose-ranging adaptive design to determine the efficacious doses for the late-phase clinical trial. Phase 2 & 3 study design, conduct, data analysis, interim analysis (IA), and clinical study report (CSR). Support drug safety update report (DSUR), periodic safety update report (PSUR), Investigator's Brochure (IB), and Briefing Book (BB) activities.
Led the statistical strategy and participated as a core member for the new compound clinical development plan. Contribute to study design, sample size estimates, protocol development, statistical analysis plan, data specs, programming specs, and case report form (CRF).
Led creation of randomization schedule specs for clinical study; supported safety data review for early phase and late phase study.
Led integrated summary of efficacy and safety analyses (ISE/ISS), interim analysis (IA), and final analysis. Support an independent data monitoring committee and global NDA/BLA submissions to health authorities.
Pharmacokinetic (PK) and pharmacodynamic (PD) data analyses for phase 1 trials, including single/multiple ascending dose (SAD/MAD) study, bioequivalence study (drug-drug interaction, food effect, formulation), and PK/PD data on the special populations.
Supported oversight of 340B program initiatives and compliance activities, where applicable.
Professional Experience:
National Institutes of Health (NIH) – Bethesda, MD Jul 2024 – Mar 2026
Project Manager /Biostatistician (Market Access/Pharmacoepidemiology)
Managed the design and supported the design of clinical databases in alignment with study protocols and requirements, including the creation of edit checks and dynamic functionalities.
Led, supported, and developed a large clinical team, ensuring high service quality through training & development, collaboration with staff and administration, and continuous improvement.
Ensured all observational studies complied with FDA guidance, Good Clinical Practice (GCP), and international regulatory standards, including ISO 14155 and EU MDR.
Clinical & administrative oversight of all mental health programs for children aged 0-10 (including determining operating policies and practices).
Managed clinical education, training, and hands-on support to healthcare providers on advanced wound care protocols.
Led the full lifecycle of oncology and virology real-world evidence (RWE) studies, including study design, protocol writing, statistical analysis plan (SAP) development, Power BI, Data Lake, Azure DevOps, ArcGIS, SAS, R, SQL, Tableau, and final reporting.
Developed and validated Bayesian adaptive trial simulations to optimize study design and increase statistical power.
Conducted feasibility assessments by leveraging large healthcare claims and EMR databases to identify suitable patient populations and endpoints.
Collaborated with cross-disciplinary teams (clinicians, statisticians, regulatory, data scientists) to integrate epidemiological insights into drug development strategies using Agile methodologies.
Supervised data quality assurance processes, ensuring the integrity of real-world data (RWD) sources used in study analysis.
Authored clinical study reports (CSR) and manuscripts for regulatory submissions and peer-reviewed journals.
Managed data analytics of EHR and Real-world claims data (data from hospitals and clinics).
Managed development training programs for compliance awareness.
Conduct User Acceptance Testing (UAT) to validate clinical database functionality and accuracy.
Managed the construction of end-to-end data science solutions to improve healthcare outcomes and reduce costs.
Oversaw advanced conversational AI solutions to improve healthcare experience.
Supported oversight of 340B program initiatives and compliance activities, where applicable.
CSCC with City of Chicago – Chicago, IL Jun 2022 - Jun 2024
Biostatistics Program Director
Designed observational studies assessing epidemiologic trends relevant to oncology and infectious diseases, including protocol and SAP development.
Oversaw, reviewed, and approved study-specific CDM documentation such as Data Management Plans (DMPs), Case Report Form Completion Guidelines (CCGs), Data Transfer Agreements (DTAs), and EDC specifications.
Managed translation of business problems into precise analytical solutions with measurable business metrics.
Oversaw effort together with investigators to establish clinical data workflows for established and emerging studies.
Supervised survey design, protocol writing, and data management for violence prevention research.
Conducted extensive literature reviews and meta-analyses to inform study hypotheses and design parameters.
Led feasibility analyses to assess data availability and quality within city health databases for oncology-related conditions.
Developed interactive dashboards using GIS, Tableau, Azure DevOps, Data Lake, and Power BI for real-time monitoring of study metrics and health outcomes.
Coordinated with public health officials and external research partners to align study goals with regulatory and community health priorities.
Trained junior epidemiologists and analysts on observational study methodologies and regulatory compliance.
Oversaw preparation of budgets and ensured compliance with allocated funding ($2,000,000.00).
Provided strategic leadership and oversight of the Compliance function.
Led the development and maintenance of compliance policies and procedures.
Provide leadership through a thorough understanding of both clinic and home-based models of early childhood mental health service provision
Build and cultivate strong partnerships with funding and contracting agencies
As part of the Executive Team, play a key role in helping develop and execute We Care’s strategic plan
Managed data analytics of EHR and Real-world claims data (data from hospitals and clinics).
Supported oversight of 340B program initiatives and compliance activities, where applicable.
Texas Department of State Health Services – Austin, TX Oct 2021 - Jun 2022
Biostatistics Manager (Epidemiology/ Market Access)
Managed RWE studies supporting oncology and virology drug development through collaborations with pharmaceutical sponsors.
Drafted and reviewed study protocols, SAPs, and data management plans for observational cohorts.
Managed timely and accurate filing of CDM documentation in the Trial Master File (TMF).
Oversaw integration of diverse data sources, including EMRs, claims, and laboratory databases for comprehensive analysis.
Implemented Bayesian hierarchical models to estimate risk-adjusted outcomes across heterogeneous populations.
Ensured rigorous compliance with FDA regulations, GCP, and international standards during all phases of observational research.
Applied advanced survival and longitudinal statistical modelling techniques to assess treatment effectiveness and safety outcomes.
Contributed to regulatory briefing documents and investigator brochures for investigational oncology agents.
Submitted >900 cases to CDC via NEDSS; led Bayesian survival modelling for high-risk populations.
Supervised and guided junior CDM staff on assigned studies.
Tarrant County Public Health Department – Fort Worth, TX Sep 2020 - Oct 2021
Clinical Data Manager/ Epidemiologist
Led epidemiologic investigations and outbreak surveillance activities focus on cancer-related risk factors and infectious comorbidities.
Managed collection, cleaning, and analysis of large-scale COVID-19 vaccination and morbidity data to identify potential impacts on oncology patient populations.
Utilized REDCap, GIS, and Tableau to streamline data capture and reporting for ongoing observational studies.
Collaborated with clinical teams to refine study endpoints and improve data completeness and accuracy.
Developed data use agreements and ensured HIPAA compliance for sensitive patient data utilized in research.
The Centers for Disease Control and Prevention (CDC) – Dallas, TX Jun 2019 - Sep 2020
Public Health Consultant
Provided medical expertise to provide clinical, epidemiologic, and technical consultation and guidance in response to reports of illness in travelers.
Managed daily operations of the morning shift at the CDC Dallas/Fort Worth (DFW) Quarantine Station.
Generated electronic and written records related to the public health risk assessment performed during the primary, secondary, and tertiary entry screening process.
Guided agencies and organizations on assessing health education needs and, on the development, and delivery of health education programs.
Managed training and pharmacoepidemiologic and health-related workshops for new employees and facilitated existing recertification.
Promoted health education and risk reduction through presentation of educational programs.
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