Kyle Ireton, Phd Email & Phone Number

South San Francisco, California, Us

● Represent Biometrics on projects and study teams. Lead statistical programming deliverables including: generation of data visualizations or summary reports to support internal decision making and regulatory interactions (IND/CTA filings, annual safety reporting, etc.); providing input for statistical analysis plans, study protocols and clinical study reports; reviewing study randomization specifications; collaborating with Clinical Data Management on case report form design, data review plans, and external data transfer specifications; collaboration with the studyteam to review data and manage timelines; oversight of Biometrics CRO deliverables.● Design, develop, and validate CDISC analysis data (i.e., SDTM, ADaM) for use with statisticalreporting code and analytics applications.● Develop and manage reusable code for interactive data visualization, exploratory analysis, and statistical summaries in clinical study reports.● Work with the Biometrics Team to establish innovative processes to ensure high data quality,reporting of analysis results, and analysis reproducibility.● Support the Biometrics Team in efforts to build, maintain, and continuously improve an Rinfrastructure that is suitable for regulatory submission work.

Morrisville, Nc, Us

- Driving collaboration with Pharmaverse working group for open-source workflow definition in for end-to-end (E2E) examples (see https://github.com/pharmaverse) - Working hand-in-glove with open-source leaders to test and troubleshoot developmental Pharmaverse packages for SDTM, ADAM, TLGs, leading to bug resolutions and optimization- Guiding and mentoring Vendor & Sponsor teammates on R, Python, and Git / Github tools for next-generation manual and automated creation of SDTMv, ADAM, and TLG / TLF outputs + version control- Supporting sponsor molecular group across 4 Phase II oncology trials, including early adopter “next gen” workflow study using R programming, Python orchestration, and Git version control with SAS QC- Providing internal R training curriculum development, training sessions, and presentations- Consulting as R Subject Matter Expert for internal groups, across Vendor FSP and FSO teams- Led Syneos community team in Pharmaverse Admiral Hackathon adapting R templates (esp, ADSL)- Developed internal R package to deliver automated SDTM outputs for Sponsor- Created R Teal / Shiny apps for interactive visualization of clinical safety data (ADSL, ADAE, etc.)- Shared exploratory R Markdown ADAM scripts in managed environments (BEE, enableR) - Wrote FL & QC programs in SAS & SQL in EntimICE IDE for production quality outputs (SDTM-TLG)- Create and QC necessary specifications and metadata documentation

Alameda, California, Us

- Lead Preclinical development for 2 key neuromodulation medical devices from R&D to clinical trials- Coordinate study designs with 5 CRO partners to deliver crucial pre-GLP and GLP studies- Wrote FDA Presubmission with key Clinical and Regulatory stakeholders to communicate new neuromodulation research roadmap for novel medical device - Analyze experimental electrical signals to ensure quality of device development- Recruit Clinical KOLs for project developtment, leading slide deck presentations and facilitating conversation with Preclinical, Clinical, and Regulatory teams- Recruited Clinical Science lead for neuromodulation project

Davis, California, Us

- Owned experimental design, data collection, analysis, and interpretation for 2 long-term decision-making behavior research projects with multiple stakeholders, resulting in production of 3 papers- Wrote Python scripts for instrumental data collection of >100 individual animals for 3 papers- Invented R (RMarkdown) pipeline to clean, wrangle, and engineer structure for millions of rows of raw instrumental data, to enable “big data” analyses and save hundreds of hours of manual labor- Applied ANOVA, linear mixed-effects, and exponentially-modified Gaussian models in R for visualization & analysis pipelines to deepen insight into animal behavior for 3 papers - Led feature engineering to guide linear and logistic classifier models, and Hidden Markov Models, to predict animal behavior and genotype for 2 manuscripts- Built classifier models with linear and logistic regression from animal behavior variables to predict animal genotype from behavior phenotypes- Applied Principal Component Analysis to identify key drivers of individual variability in animal behavior- Initiated data science methods and framework which persist for all new high-throughput behavior experiments in 3 laboratories- Mentored diverse team of direct reports (5 Undergraduates, 2 Technicians, 1 MS student)- Taught RMarkdown pipelines for data wrangling & visualization to 3 PhD students, 2 Technicians, and 6 undergraduates starting from no previous programming background

Oakland, California, Us

- Programmed >10 Python microcontroller scripts for sophisticated animal behavior experiments- Wrote >10 R scripts for statistical analysis and visualizations of animal behavior.- Identified biased animals behaviors from behavior analysis, and designed new behavior equipment as engineered solution to mitigate bias in subsequent experiments.- Led numerous animal learning behavior studies (Morris Water Maze, Y-maze Novel Arm Recognition, Novel Object Recognition) including experiment design, analysis, and interpretation- Led numerous emotional animal behavior studies (Open Field, Elevated Plus Maze, Fear Conditioning)- Managed animal colonies with hundreds of mouse cages and thousands of mice over 5.5 years, with responsibilities including animal husbandry, genotyping by PCR, and accounting organization

North Bethesda, Maryland, Us

Interrogated neural circuitry of addiction using optogenetics in transgenic mouse lines. Specifically investigated behavioral contributions made to aversive conditioning by vesicular glutamate transporter 2(VGluT2)- and glutamate decarboxylase(GAD)-expressing neurons projectioning from ventral tegmental area to lateral habenula. Presented work in poster form, data published later in "Role of glutamatergic projections from ventral tegmental area to lateral habenula in aversive conditioning", Journal of Neuroscience 34(42), October 2014.

Uy

Assisted in investigations into characterization of phenotypic transformation of microglia into reactive astrocytes "in vitro" and "ex vivo", in a transgenic murine model. Reactive astrocytes are associated with disease onset in an inherited model of ALS. Translated text and ideas from Spanish to English in ensuing publication (see attached link to full article). Learned essential neuroscience techniques, such as cell culturing, perfusion, slicing spinal cord and brain sections, and confocal microscopy.

Corvallis, Or, Us

Executed research project to determine whether oxytocin is capable of rapidly inducing phosphorylation of myristoylated alanine-rich C kinase substrate (MARCKS) protein in the ovine endometrium, presumably leading to cellular secretion of PGF2a, serving as a conceptual basis for investigations into rapid regulatory activity by estrogen. Presented project conclusions in powerpoint form at 2011 OSU HHMI Summer Symposium (see attached file above). Selected as a "Top Speaker".

Us

Utilized various biochemical lab techniques (DNA mutagenesis, PCR amplification, E. Coli transformation, PhastGel DNA analysis, FPLC protein purification, SDS-PAGE analysis, HSQC NMR analysis, and PyMol protein modeling) to identify small-molecule cancer-fighting compound. Analyzed data, and presented findings in lab meetings/research symposium.

Corvallis, Or, Us

Administered anesthesia during surgeries, performed surgery on sheep to collect tissue samples, and carried out laboratory bench work (protein, DNA, tritiated-estradiol radioreceptor assays) to help characterize the estrogen plasma membrane receptor in ovine endometrium. Analyzed data and presented research in HHMI research symposium.

Raised funds and recruited volunteers for Democratic National Committee via GCI during 2008 presidential election as door-to-door canvasser. Led canvassing crews in Portland, OR neighborhoods, personally raised over $3,000.

Doctor Of Philosophy (Ph.D.), Neuroscience

Honors Bachelor Of Science, Biochemistry & Biophysics

Biochemistry & Biophysics, Biochemistry