Aysheh Alrfooh, Ph.D.
Somerville, MA | linkedin.com/in/aysheh-alrfooh | aisha@alrfou.com
SUMMARY
Pharmacist and Ph.D.-trained scientist in Clinical Pharmaceutical Sciences with multidisciplinary expertise spanning clinical data management, clinical trial operations, translational bioinformatics, computational biology, and biostatistics. Experienced across the drug development continuum—from target population discovery, multi-omics, and preclinical PK/PD biomarker analysis to leading clinical data management, eCOA/ePRO endpoint design, automated R clinical reporting, vendor/CRO oversight, and database lock for rare disease programs under ICH E6 (R2) / GCP and CDISC standards. Combines deep scientific and clinical pharmacology grounding with strong computational execution and cross-functional leadership to turn complex biological and clinical study needs into inspection-ready systems and actionable insights.
PROFESSIONAL EXPERIENCE
Scientist II, Clinical Data Management | Clinical Operations, Diagonal Therapeutics, Watertown, MA (Mar 2025 – Sep 2026)
• Led clinical data management across two rare disease studies at different lifecycle stages: a multi-country clinical study from start-up through active conduct and an HHT natural history study taken through database lock and close-out, keeping both inspection-ready under ICH E6 (R2) / GCP and CDISC standards.
• Served as the primary scientific and technical contact for the CRO and EDC (Medidata Rave), IRT, eCOA, ECG, and PK/PD vendors through database build, configuration, validation, UAT, go-live, and ongoing issue resolution.
• Directed database lock and full close-out of the HHT natural history study, completing final clinical data analysis, quality review, external data reconciliation, and archival of 600+ TMF documents in Veeva Vault.
• Owned the TMF for the multi-country clinical study: authored the Sponsor TMF Management Plan, defined the TMF Responsibility Matrix with the CRO, maintained the ClinOps TMF Mapping, and performed ongoing document classification and index reviews across all zones per the CDISC TMF Reference Model v3.0.
• Built and maintained an automated R reporting framework that produced daily and monthly eCOA compliance reports with real-time QC flags, issue trackers, and recommendation slides, enabling rapid site follow-up, data correction, and evidence-based protocol amendment discussions.
• Independently designed a scalable, reproducible R framework to process and visualize longitudinal ePRO compliance, disease severity trends, and data quality in the natural history study, shaping clinical development strategy and informing the design of the multi-country clinical study.
• Designed eCOA/ePRO questionnaire content, reviewed configuration specifications across multiple versions, and presented the endpoint design strategy to the Program Development Team before go-live, improving data capture quality and reducing patient burden.
• Reviewed eCRF, IRT, randomization, and edit check specifications against country-specific protocols, the Data Management Plan (DMP), and external Data Transfer Specifications (DTS), and prepared data migration into study systems.
• Conducted monthly external data reconciliation (aligning central ECG vendor data with EDC ECG eCRFs) and analyzed EDC query trends to separate site-driven from system-driven queries, refining eCRF questions to reduce query volume and preparing clinical data reports for Safety Review Committee (SRC) meetings.
Scientist, Bioinformatics | Informatics, Diagonal Therapeutics, Watertown, MA (Jun 2023 – Mar 2025)
• Integrated and analyzed multi-omics datasets (TCGA, CPTAC, Bioturing) and large-scale human biobank cohorts (UK Biobank) to uncover disease mechanisms, identify predictive biomarkers, and define target patient populations and stratification strategies for rare genetic disease programs.
• Conducted preclinical PK/PD and translational biomarker analyses in rats and non-human primates and presented results to leadership, directly contributing to securing $128M Series A funding for the HHT program.
• Partnered with the clinical team to lead initial analytics for the HHT natural history observational study, building a scalable R framework to process and visualize ePRO data on disease severity, patient compliance, and data quality that transitioned into clinical operations.
• Collaborated closely with biology, clinical, development, and operations teams to define rare disease cohorts, characterize comorbidity patterns, contextualize findings with published literature, and resolve critical data gaps to guide program decisions.
Co-op, Computational Biologist | Translational Analytics Group, Research Data Science, Biogen, Cambridge, MA (Jan 2023 – May 2023)
• Evaluated and benchmarked single-cell RNA-seq and spatial gene expression algorithms across R and Python packages to determine performance characteristics and improve Biogen's translational analysis pipelines.
• Refined statistical analysis pipelines for single-cell transcriptomics through theoretical exploration and exploratory simulations of spatial correlation structures, model forms, missing data imputation strategies, QC filtering, and visualization approaches.
• Integrated human single-cell RNA-seq datasets across diverse tissue systems to support translational research and target discovery.
Doctoral Researcher | Pharmaceutical Sciences & Experimental Therapeutics, College of Pharmacy, University of Iowa, Iowa City, IA (Aug 2017 – Dec 2022)
• Built end-to-end computational pipelines in Linux and R for targeted bisulfite sequencing (Ion S5 NGS) and Illumina EPIC methylation arrays, including FASTQ preprocessing, variant calling (bcftools, Bis-SNP, vcfR), differential methylation (MethylKit, limma), and methylation-eQTL analysis (Matrix eQTL).
• Investigated clinical and postmortem cohorts in bipolar disorder, demonstrating locus- and region-level DNA methylation alterations and global inflammatory cytokine/gene expression dysregulation (clusterProfiler, QIAGEN IPA) associated with suicidal behavior across 40 suicide-related SNPs.
• Modeled longitudinal DNA methylation trajectories in autism spectrum disorder (ASD) vs. developmentally delayed and typically developing cohorts using linear mixed models, and analyzed genome-wide methylation changes and Horvath epigenetic age acceleration in schizophrenia.
• Conducted wet-lab and translational neurogenetics studies, including primer design, allele-specific methylation at the HTR2A locus in substance use disorder, and expansion, QC, and reprogramming of patient-derived iPSCs into cortical forebrain neural progenitor cells (NPCs).
TECHNICAL SKILLS
• Clinical Data & Operations: End-to-end study start-up through database lock & close-out, Data Management Plan (DMP) & Data Transfer Specification (DTS) review, eCRF/IRT/edit check specification review, UAT, query management, external data reconciliation (ECG, eCOA/ePRO, PK/PD), Safety Review Committee (SRC) reporting, CRO & vendor oversight, MedDRA, WHODrug
• Clinical Systems & Standards: Medidata Rave (EDC), Veeva Vault (eTMF), Suvoda & eCOA/ePRO platforms, IRT, ICH E6 (R2) / GCP, CDISC standards, CDISC TMF Reference Model v3.0
• Data Science & Biostatistics: R / Bioconductor (automated reporting pipelines, QC flagging, data wrangling, visualization), Python, Linux/Bash, linear mixed models, logistic regression, longitudinal cohort modeling, algorithm benchmarking
• Bioinformatics & Translational: Multi-omics integration (TCGA, CPTAC, Bioturing), UK Biobank cohort & comorbidity analysis, PK/PD & biomarker analysis, single-cell RNA-seq, spatial transcriptomics, targeted bisulfite sequencing, EPIC DNA methylation, variant calling (bcftools, Bis-SNP), eQTL & pathway enrichment (QIAGEN IPA)
EDUCATION
• Ph.D., Clinical Pharmaceutical Sciences | University of Iowa, Iowa City, IA (2017 – 2022) | GPA: 3.81/4.0
• Certificate in Biostatistics | University of Iowa, Iowa City, IA (2020 – 2021) | 15 S.H.
• B.S., Pharmacy | University of Jordan, Amman, Jordan (2010 – 2015) | GPA: 3.73/4.0