Ermias Tilahun

Epidemiologist and data scientist with 10+ years of experience spanning FDA, Pfizer, and academia, specializing in clinical safety data review, pharmacoepidemiology, and real-world evidence (RWE) generation for regulatory decision-making. Direct FDA contracting experience reviewing NDA/BLA submissions and drug labeling, applying CDISC SDTM/ADaM standards and safety datasets to assess safety data sufficiency and adverse event findings (TEAE, SAE, AESI). Proven track record integrating heterogeneous, multi-source health data (claims, EHR/EMR, MarketScan, Optum, FAERS, NPDS, NSDUH) into actionable evidence for oncology, infectious disease, and pharmacovigilance programs across federal and global health settings.

PhD in Pharmacoepidemiology with expertise in surveillance analytics, RWE methodology, ECA/Target Trial Emulation design, and R-based safety data analysis.

Clinical Development Advisor - Horn of Africa Clinical Trials (HACT) - Clarksburg, MD

(2025-06)

• Led development of GCP- and FDA-aligned clinical operations infrastructure, including a comprehensive Clinical Operations SOP and 18 supporting quality SOPs covering CAPA, change control, monitoring, vendor management, and risk-based quality management.
• Directed evaluation and implementation strategy for AI-enabled protocol review and literature abstraction tools, benchmarking platforms.
• Advise on clinical development strategy, research workflows, protocol implementation, and data management processes for observational and interventional studies.
• Collaborate on quality management systems, research governance, and scalable operational frameworks aligned with ICH E6/E8 and global clinical research standards.

Senior Contracting Epidemiologist / Team Lead - Aneon Federal Solutions / FDA - Silver Spring, MD

(2023-06 - 2025-05)

• Led multiple complex epidemiologic and surveillance/real-world evidence studies supporting oncology, pharmacovigilance, postmarketing surveillance, and regulatory decision-making within a federal agency environment.
• Applied observational epidemiology and surveillance analytics methods to evaluate safety and public health questions using largescale, multi-source healthcare and surveillance datasets covering multimillion patient records.
• Developed study concepts, protocols, and analysis plans; guided a team of six analysts through implementation and interpretation.
• Prepared scientific summaries, briefing materials, and technical reports translating complex surveillance findings for multidisciplinary stakeholders, supporting multiple regulatory submissions and reviews.
• Directly reviewed NDA/BLA submissions and proposed drug labeling for safety data sufficiency, applying CDISC SDTM/ADaM standards and safety datasets to support TEAE, SAE, and AESI assessments.
• Collaborated with clinicians, statisticians, epidemiologists, and regulatory scientists on evidence generation activities.

Contracting Health Data Scientist - Brilliant Corp. / FDA - Silver Spring, MD

(2020-06 - 2023-05)

• Supported epidemiologic and safety surveillance studies using MarketScan, Optum, NPDS, NSDUH, and FAERS-related datasets spanning multimillion records, integrating heterogeneous data streams into structured analyses.
• Conducted data quality review, analytic validation, and surveillance-related analyses supporting public health and safety evaluations for a federal regulatory agency.
• Contributed to workflow improvements and agency guidance involving real-world data and national surveillance systems.
• Translated scientific and public health questions into structured analytic approaches, delivering actionable analyses and reports to agency stakeholders.

RWE Research Scientist (Epidemiology / RWE) - Pfizer Pharmaceuticals - New York, NY

(2017-10 - 2018-11)

• Designed observational and epidemiologic studies and contributed to protocol and statistical analysis plan development.
• Managed and analyzed a global invasive pneumococcal disease surveillance database spanning more than 20 countries, translating multi-country surveillance data into evidence for infectious disease decision-making.
• Developed evidence summaries, predictive/statistical forecasting models, and technical reports supporting infectious disease surveillance and vaccine-related research.
• Collaborated with multidisciplinary global teams on epidemiology and evidence generation initiatives.

Graduate Teaching & Research Assistant - Howard University - Washington, DC

(2013-08 - 2019-07)

• Supported epidemiologic and health outcomes research through literature reviews, survey design and validation, quantitative and predictive/statistical modeling analysis, and scientific reporting.
• Conducted structured literature reviews and evidence synthesis supporting manuscripts and scholarly work.
• Assisted with academic instruction, mentoring, and student support activities; collaborated on public health and pharmacoepidemiology research projects.

Monitoring & Evaluation Specialist - Management Sciences for Health (MSH) - Ethiopia

(2010-05 - 2013-05)

• Led monitoring, evaluation, and data quality improvement activities across multisite public health and infectious disease surveillance programs.
• Supported analysis and interpretation of routine surveillance and programmatic data to inform public health decision-making.
• Supervised implementation of reporting standards and data quality assurance activities aligned with programmatic biomedical data standards.
• Collaborated with healthcare facilities and multidisciplinary teams to strengthen program performance monitoring.

Pharmacovigilance Intern - Management Sciences for Health (MSH) - Arlington, VA

(2015-04 - 2015-11)

• Conducted systematic literature reviews and synthesized multi-source safety evidence supporting pharmacovigilance activities.
• Assisted with preparation of scientific documentation and evidence summaries; supported structured safety monitoring and reporting activities.

PhD - Pharmacoepidemiology - Howard University School of Pharmacy (2019)

Master of Public Health - Public Health - Haramaya University (2011)

BSc - Physician Assistant Studies - Haramaya University (2006)