Amro Ali
Local Available Immediately
******.****@*****.***
Summary:
A highly experienced Technical Data Consultant/Pharmacoepidemiologic Director with over 12 years of expertise in public health, clinical trials, infection prevention, and epidemiology, leveraging advanced statistical methodologies, including Bayesian approaches, for data-driven decision-making.
Developed and managed complex statistical analyses for large datasets using tools like SAS, SQL, Tableau, PowerBI, REDCap, and R, with expertise in Bayesian regression, hierarchical models, and predictive analytics to derive actionable insights in population health, pharmacoepidemiology, oncology, and virology research.
Skilled in RWD and RWE management, including Bayesian methods for real-world evidence synthesis, cloud platforms, data virtualization, and data repository development.
Delivered high-impact data science solutions supporting clinical and organizational needs, with specialization in Bayesian adaptive trial designs and meta-analyses.
Adept in HEOR, protocol development, and regulatory compliance, integrating Bayesian frameworks to improve trial efficiency and evidence generation.
Collaborated with stakeholders across NIH, CDC, and other Federal health agencies, contributing to data-informed strategies in healthcare, pharmacoepidemiologic surveillance, and Bayesian modeling for therapeutic evaluation (Moderna, BioSpace, Gilead, and J&J).
Proven ability to provide support across a variety of therapeutic areas, with advanced knowledge in Bayesian methodologies applied to oncology and virology.
Managed multidisciplinary teams to integrate Bayesian statistical modeling into program development and analysis, ensuring compliance with regulatory and clinical standards.
Education:
Master of Public Health– Epidemiology, Walden University School of Public Health, Minneapolis, MN
M.D. - Medicine
Windsor University School of Medicine (Cayon Campus), Cayon, Saint Mary Cayon Parish
Bachelor of Science– Healthcare Management, Texas University at Dallas, Dallas, TX
Associate of Science – Science, Richland College, Dallas, TX United States
Professional Experience:
National Institutes of Health (NIH) Jul 2023 - Jul 2024
Technical Data Consultant~ Biostatistics Market Access/Pharmacoepidemiology
Managed statistical analysis of large, complex datasets using SAS, SQL, PowerBI, REDCap, R, Microsoft Visio, Tableau, Ticketing Software, command data repository (IQUVIA and EDI897) and SPSS for population health research and pharmacoepidemiology using existing publicly available datasets collected by NIMHD principal investigators involving statistical procedures varying in complexity from simple bivariate tests to advanced regression methods for longitudinal data analyses and time-to-event analysis.
Managed the design and execution of virology RWE research projects using administrative claims data and EMR including development of protocols and contributed to statistical analysis plans (SAPs).
Managed collaboration with internal and external experts to generate rigorous scientific data, and contributed to development of dissemination plans, as aligned with the Integrated Evidence Team (IET) to support the RWV&E strategic plans for the assigned therapeutic areas.
Managed the design and delivery of data science and AI solutions and models to support biostatistical analysis and broader commercial organizational needs.
Developed and maintained an end-to-end data repository to enable the use of analytical methods and machine learning techniques for pattern recognition and insight generation.
Managed HEOR research using internal data sets including writing protocols and statistical analysis plans, defending in protocol review committee, and executing research with analyst to writing final reports and publications using prospective, retrospective, modelling, PRO's, meta-analyses and hybrid designs.
Oversaw designing and implementing data models and algorithms to support virology RWE initiatives.
Implemented Bayesian regression models to analyze longitudinal virology datasets, improving insights into time-to-event outcomes and treatment efficacy.
Designed Bayesian adaptive trial simulations to optimize sample sizes and enhance decision-making for virology RWE projects.
Designed data collection forms and data structure for Led development & integration of COA measurement strategy into clinical development programs through clinical trial program support (protocol/SAP content development).
Created complex design and analysis of pharmacoepidemiology studies within pharmaceutical settings in research to support clinical trials of drug development.
Created code lists for medications and diagnoses using ICD-10-CM, HCPCS and NDC.
Managed developing analysis plans in different stages of the drug development lifecycle.
Oversaw global clinical evidence requirements, including regulatory paths, understanding all applicable standards and regulations in clinical evidence generation and dissemination, including Good Clinical Practice (GCP), FDA requirements, EU MDR (ISO14155, CFR Part 812 and MedDev 2.7.1 (rev4)).
Managed RWD assets and established data curation plans including provisioning data licenses and data platforms in collaboration with medical affairs statistics, pharmacoepidemiology, oncology and virology RWE leadership teams ((Moderna, BioSpace, Gilead and J & J).
Developed performance metrics from cost information to help improve profitability, on-time delivery and quality production.
Managed evaluation of infection control programs by identifying strategies that address the risk of infection transmission.
Oversaw educational programs related to infection prevention and control.
Managed the implementation of MGB occupational health policies and procedures which assess, mitigate, and respond to occupational infection risk.
Oversaw collaboration with infection prevention stakeholders (Environmental Health and Safety, Compliance, Methodist Health system, Swedish Hospital and Central Sterile Processing).
CSCC With City of Chicago Jun 2022 - July 2023
Director of Data Modernization IT
Designed complex data reports, visualization reports, dashboards, tables, charts, and graphic displays.
Managed difficult manipulation of epidemiologic data using statistical software such as: SPSS, SAS, Snowflake, R-Studio, SQL, REDCap, PowerBI, Tableau and ArcGIS.
Managed research of epidemiologic literature to obtain information for inclusion in reports and studies recommending methods of reducing violence and crime rates in Chicago and designed data collection and management processes.
Supervised the design and administration of surveys, Identified and evaluated non-traditional data sources and tools for epidemiologic surveillance.
Launched violence prevention projects and led meetings and mayoral initiatives with city departments, community partners and stakeholders to whom I presented CSCC weekly data updates addressing target populations at risk of high crime rates especially homeless individuals and families with challenging housing situations.
Critically appraised existing epidemiology evidence and created new evidence of data visualizations and dashboards through delivery of specific research plans, protocols and analysis of epidemiologic databases available within the City of Chicago such as the CDPH and CPD websites, CrimeLab and Chicago Data Portal.
Managed continuous improvement of infection prevention and control practices at clinics that was supervised by CSCC.
Managed infection prevention liaison to regulatory agencies and public health authorities and served as a representative on external committees.
Oversaw preparation of budgets and ensured compliance with allocated funding ($2,000,000.00).
Texas Department of State Health Services Oct 2021 - Jun 2022
Technical Data Lead~ Epidemiology/ Market Access
Led epidemiology investigation teams in fighting the COVID-19 epidemic where I have utilized SAS, SPSS, Microsoft Excel, Access, Tableau, SnowFlake and other statistical software packages to conduct COVID death surveillance and analysis of trends of concern to public health officials and pharmaceutical representives.
Applied Bayesian network models to understand the interaction of comorbidities and medication safety in pharmacoepidemiologic studies.
Managed and analysed EHRs including medical history, medical prescriptions and pharmaceutical products while conducting fatality investigations to determine case status for accurate state level fatality reporting.
Managed epidemiologic data, educated and advised patients regarding guidelines and resources.
Submitted over 235 fatality cases of the year of 2020 and over 680 fatality cases of the year 2021 of region 7 to The CDC using NEDSS.
Led analysis of pharmacoepidemiologic studies using large administrative and real-world EMR systems including specialized EMR systems to support biomarker and drug development activities with external partners (Moderna, BioSpace, Gilead and J & J).
Created complex pharmacoepidemiologic reports using RStudio, mediation analysis, repeated measures, structural equation modelling, multi- level modelling, propensity score weighting, interrupted time series and survival analysis.
Served as an Infection prevention supervisor where I developed and maintained an effective system for the surveillance of specific health settings associated infections as designated by The Infection Control Committee, Tenet Corporate Quality Program and The Public Health Department to serve Baylor, Parkland and Plano Regional Hospital.
Managed the infection prevention team data evaluation and analysis using sound epidemiological principals as recommended by APIC, CDC and SHEA.
Managed and communicated surveillance data to The Infection Control Committee.
Managed teams of epidemiologists and clinical researchers to develop protocol and analysis plans for RWE and RWD studies.
Managed multi-functional projects and interacted with biomarker scientists and scientists from other functions (Moderna, BioSpace, Gilead and J & J) including clinical pharmacoepidemiology, bioinformatics and clinical research.
Managed clinical trial design, in particular identification of the target population, protocol development, patient recruitment and patient medical history data ascertainment.
Managed medication safety evaluation: provided background event rates, synthesized existing evidence including through meta- analyses and identified high-risk populations.
Conducted Bayesian survival analysis to assess the effectiveness of interventions in reducing mortality among high-risk populations.
Represented the Bureau in collaboration with other state departments to create and maintain shared databases and informational platforms on health-related issues.
Managed development of policies and procedures to conform and comply with agency standard cyber security policy design related to information risk management, designation of data as to criticality, confidentiality, and protection.
Tarrant County Public Health Department Sep 2020 - Oct 2021
Data Lead Manager/Epidemiologist
Managed epidemiologic investigations (over 2500) tracing cases, contacts, sources, places and groups of exposure of communicable and non-communicable diseases.
Managed data of mobile sites of COVID-19 vaccines where I was responsible for reviewing and monitoring all epidemiologic cases submitted from The Texas Christian University and The University of Texas at Arlington to Tarrant County Public Health Department using Quickbase data system.
Managed Quickbase data and surveillance used by The Tarrant County Public Health Department.
Managed submission of epidemiologic cases and vaccination data and eliminated data bias within the system.
Managed Implementation of system infection prevention and control goals, plans, and standards consistent with the clinical, administrative, regulatory and legal requirements and objectives of the organization.
Managed implementation of site surveillance, remediation, and reporting of infections, including outbreak detection and response.
Trained new epidemiologic investigators on conducting efficient public health interviews and tracing contacts and sources of exposure of COVID-19.
Abounding Prosperity Jul 2020 - Jul 2021
Technical Data Epidemiologist ~ Pharmacoepidemiologist/ Market Access
Oversaw organization of Infographics of the organizational milestones for the last 15 years, HIV-STI-Hep C and implemented them into Athenahealth data system and trained clinical staff on using Athenahealth data system to submit EMRs.
Developed a poster presentation of the organization pharmacoepidemiologic data and multiple dashboards using PowerBI and Tableau.
Designed database management systems and analysis using multiple software including SAS, SAPs, 4HANA, command data repository (IQUVIA and EDI897), Snowflake, SPSS, Access Microsoft and Excel.
Served as main point of contact through the end of the HIV prevention grant term with The CDC and The Texas Department of State Health Services.
Created an epidemiologic profile of Black Women and MSM seeking STI services that begin to use PrEP as an HIV prevention tool.
Managed analytic support for grant-related activities, budgets and operations related to the grants including epidemiologic data analysis and program.
Supervised HIV Prevention campaigns to identify opportunities for improving HIV intervention programs in target populations in homeless shelters and provided housing for patients with critical care needs.
Used Bayesian framework to create dynamic models for understanding the impact of PrEP adoption on HIV prevention within key populations.
Obtained Significant experience applying epidemiologic methods to study a variety of questions in support of medicine development (safety, effectiveness and natural history of disease).
Demonstrated experience leading pharmacoepidemiologic research programs in a drug development environment and clinical trial.
Improved disease understanding relevant to drug development: Incidence, prevalence, risk factors, natural history course, treatment patterns, comorbidities, co-medications, outcome measures, phenotypes, biomarkers, unmet needs and their variations across domains such as demographics and geographies.
Managed teams cross functionally with registry stakeholders across medical affairs, pharmacovigilance, regulatory affairs, scientific communications and clinical development.
Managed meetings with external stakeholders to ensure appropriate communication of pharmacoepidemiologic issues and study results including scientific advisory board members and regulatory authorities.
The Centres for Disease Control and Prevention (CDC) 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 travellers.
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 development and delivery of health education programs.
Managed training and pharmacoepidemiologic and health-related workshops to new employees and facilitated existing recertification.
Promoted health education and risk reduction through presentation of educational programs.
University of Texas Health Science Centre Mar 2016 - Apr 2019
Technical Data Manager~ Pharmacoepidemiology / Market Access
Supervised effective data management operations through staff oversight and training creating a climate of cooperation and support and promoting connectivity among The DCC and internal and external collaborators.
Managed clinical data functional team leads and staff to prioritize tasks and allocate staff to ensure delivery of expected products on an appropriate timeline within a highly dynamic environment.
Managed pharmacoepidemiologic and statistical analyses of virology data, oncology data including prostate, lung and breast cancer, and prepared results for review.
Designed Bayesian priors and performed sensitivity analyses to validate pharmacoepidemiologic study findings in oncology research.
Managed epidemiologic investigations and research of pharmacoepidemiology, communicable disease outbreaks, chronic illness conditions, disease risk factors, and other adverse health outcomes.
Managed disease surveillance systems for different public health organizations.
Interpreted results of epidemiologic investigations and compared them to health outcome data.
Managed quality of design, execution, and publication of real-world evidence studies, and quality of models and tools developed for business partners (BioSpace, Moderna and J & J).
Carbondale Memorial Hospital, Carbondale, IL Oct 2013 - Apr 2016
Technical Data Lead~ Market Access/ Epidemiologist
Executed complex quantitative analyses in support of academic planning, data informed strategic decision-making, and external reporting.
Managed cross-functional teams in the development of tools to support data integrity as part of the work of The Mason Insight Data to Analytics Solutions (MIDAS) project.
Led development, maintenance, and governance of clinical data standards by providing oversight and guidance on general policies, standard operating procedures and quality assurance processes for data collection, abstraction, analysis, submission and reporting.
Exhibited strong Clinical Data Management Practices (GCDMP), and where applicable CDISC Clinical Data Acquisition Standards Harmonization (CDASH) standards.
Managed other related special and ad-hoc duties as assigned.
Acted as a Subject Matter Expert (SME) of clinical data management techniques, processes, systems and their implementation.
Supervised analysis of protocol documents to generate study database design specifications including CRF and eCRF design, visit schedule, edit checks, system notifications, query logic, user role setup, randomization triggers, supply triggers and medical coding.
Managed quality control against associated project protocol, NIAID requirements and CRF standards templates.