PROFILE

Aysheh Alrfooh, Ph.D., is a Pharmacist and Ph.D.-trained scientist in Clinical Pharmaceutical Sciences based in Somerville, MA, with multidisciplinary expertise spanning clinical data management, clinical trial operations, translational bioinformatics, computational biology, and biostatistics. She is 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.

PROFESSIONAL EXPERIENCE

• Scientist II, Clinical Data Management | 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 under ICH E6 (R2) / GCP and CDISC standards. Served as primary scientific and technical contact for CRO and EDC (Medidata Rave), IRT, eCOA (Suvoda), ECG (Clario), and PK/PD (Resolian) vendors; owned the eTMF in Veeva Vault (600+ documents per CDISC TMF v3.0); and built automated R reporting frameworks for longitudinal ePRO compliance, severity trends, real-time QC flags, and Safety Review Committee (SRC) reporting.

• - Scientist, Bioinformatics | 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 for rare genetic disease programs. Conducted preclinical PK/PD and translational biomarker analyses in rats and non-human primates, directly contributing to securing $128M Series A funding for the HHT program.

• - Co-op, Computational Biologist | Biogen, Cambridge, MA (Jan 2023 - May 2023): Evaluated and benchmarked single-cell RNA-seq and spatial gene expression algorithms across R and Python packages; refined statistical analysis pipelines through simulations of spatial correlation structures, missing-data imputation strategies, and QC filtering; and integrated human scRNA-seq datasets across tissue systems.

• - Doctoral Researcher (Ph.D.) | University of Iowa, College of Pharmacy (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 (bcftools, Bis-SNP, vcfR, MethylKit, limma, Matrix eQTL). Investigated DNA methylation and eQTLs in bipolar disorder, longitudinal autism spectrum disorder (ASD) trajectories, and schizophrenia epigenetic aging, alongside wet-lab patient-derived iPSC/NPC neurogenetics studies.

• EDUCATION

• - Ph.D., Clinical Pharmaceutical Sciences - University of Iowa (2017-2022)

• - Certificate in Biostatistics - University of Iowa (2020-2021)

• - B.S., Pharmacy - University of Jordan (2010-2015)