Leah S. Email and Phone Number
Experienced analytical researcher with a passion for leveraging machine learning, big data analysis, & statistics to find useful insight from the large amounts of data being generated by advanced research methods. I have strong quantitative analytic insight and problem-solving skills as well as experience working on In-vitro diagnostic (IVD) development, medical device development, and assay development with next-generation sequencing (NGS) as a validation method.I also have a strong understanding of the US regulatory processes pertaining to medical devices and the quality requirements around documentation and data. R&D experience spanning analytical chemistry, immunoassays, protein-protein interaction studies, microarray technology, antibody conjugations, liquid chromatography, and NGS. Worked at the intersection of biochemistry and electrochemistry on a novel technique used to replicate DNA as well as on the development of a straight-to-consumer viral diagnostic medical device.
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Clinical Data Management Consultant- CdsBiotrinity Consulting, Llc May 2023 - Present -
Clinical Data ScientistSorrento Therapeutics, Inc. Nov 2022 - Apr 2023San Diego, California, Us• Developing a RBDMS integrated data processing program to support high performance reporting and analytics using Python; Resulted in expanded data analysis capabilities while reducing manual data review • Developing study specific annotated CRFs using knowledge of CDISC standards (CDASH & SDTM), database documentation, edit check specifications, data handling conventions and data entry instructions for two studies as the data manager, as well as assisting with user acceptance testing (UAT) on three other studies• Performing data cleaning (including query review, data transfer reconciliations, SAE reconciliation, and vendor reconciliation) with a high degree of accuracy and minimal supervision and in accordance with GCPs and SOPs• Overseeing in-house and CRO database development, maintaining study timelines, and performing oversight to meet data quality standards -
Research Laboratory ManagerProdrome Sciences Sep 2020 - May 2022Temecula, California, Us• Oversaw and scaled the analytical chemistry lab to 2x increase in personnel and 5x increase in client serum samples.• Increased LTQ Orbitrap XL mass spectrometer sample processing throughput by 300% by developing lab automation workflows using Microsoft Power Automate and Office 365 low-code solutions; Decreased sample reporting turnaround time by 25% by developing software programs using Python• Managed 3 direct reports including hiring, training, and performance management; Empowered associates to increase efficiencies in lab processes; Led continuing education trainings on regulatory affairs and quality control topics • Developed quality control methods and sample management policies to manage clinical trial samples, client samples, and biobank samples • Managed sample lifecycle for multiple programs including tracking specimen receipt, in-house testing, organization of high-quality data, final sample disposition, and reporting. • Developed the laboratory quality management system in conjunction with quality assurance, and 70% of the SOPs in the document control system; Prepared the lab for an initial inspection by the College of American Pathologists (CAP) • Negotiated external service contracts and managed vendor relations such as supplier and alternative supplier identification • Set up, maintained, troubleshooted, and extensively repaired a LTQ XL Orbitrap mass spectrometer, Gilson liquid handling system, Eppendorf microcentrifuge, SpectraMax plate reader, and Alera clinical chemistry analyzer -
Data ScientistFreelance (Self Employed) Mar 2020 - Mar 2022World, Oo- Identifying opportunities to incorporate various data sources into the dataset and develop data extraction, transfer, and loading (ETL) processes in order to create an optimal dataset for a predictive model- Designing analytical workflows to support advanced predictive model development- Using data mining, data visualization, and statistical skills to enable informed decision-making and ultimately increase the customer lifetime value; Carrying out data quality checks to ensure data are accurate and reliable -Using Python programming language with TensorFlow Keras API and NumPy, SciKit, SciPy,Pandas, Seaborn, Imblearn, and Matplotlib libraries/packages to determine suitability for modeling, perform ETL (extract, transform, load) processing, data cleansing, and develop a predictive model -Providing analytical guidance to inform marketing efforts and identify key areas for revenue growth; Generating key performance indicator (KPI) dashboards using PowerBI and/or Tableau to summarize findings. -Presented a performance analysis report on survey data from three educational programs; Summarized trends and insights into program successes and failures; Utilized various software tools and reporting services to deliver actionable data to end-users in a digestible form - Carried out statistical analysis in IBMs SPSS software, built Tableau dashboards, and integrated the dashboards into a live WIX website to facilitate the transmission and understanding of data to enable fact-based decisions to executive board and key stakeholders-Key skills included pattern identification, variable creation/feature engineering, investigating, and resolving data problems -
Transfer ScientistCue Health Inc. Feb 2019 - Nov 2019San Diego, California, Us• Developed, defined, and tested statistical analysis plans for QC; Built a QC department by obtaining material and personnel resources, training four associates, defining documentation practices, and aligning with internal departments to achieve production goals• Consolidated and transformed data in a central repository, performed statistical analysis of clinical time series data, prepared data files for MongoDB, and troubleshooted data inaccuracies, outliers, and missing values in a systematic manner • Produced and presented experimental data reports with tables, figures, and process flow diagrams for internal stakeholders and FDA. Used JMP (statistical software) and LucidChart (flow chart software) to drive project direction • Evaluated internal clinical systems for efficiency, developed protocols for handling, processing, and cleaning clinical data, and oversaw a 30% increase in in-house clinical trial enrollment and participation, bringing rates to 90%. Expanded the trial to 2 other offices and assisted in scale up processes• Transferred 40% more R&D phase protocols to development and production than any other team member in a 2 month period.• Trained 5 junior associates on various R&D methods • Used qPCR, RT-qPCR, and cell-based technologies (FACs and Countess II) to further characterize clinical samples.• Carried out RNA extractions and isolations on viral and clinical samples. -
ScientistTinoro, Inc. Jul 2017 - Oct 2018Carlsbad, California, Us• Created a data cleaning, pre-processing, and analysis pipeline that was 50% more efficient than previous processes and led to a six-fold increase in data output per experiment which ultimately led to the renewal of investor funding • Designed, optimized, and implemented new biological assays using the DOE methodology (Design of Experiments) to streamline the experimental planning process, which resulted in a more well-rounded data set • Led the scientific development efforts behind a novel non-thermal nucleic acid amplification technology using electric fields to alter the pH distribution within the solution (an alternative PCR method) • Implemented and managed process improvements in device handling and experimental protocols, which resulted in a four-fold increase in data output per experiment • Created and maintained all device-related SOPs/work instructions and improving product design using user experience concepts• Set up a system of quality control measures to improve experimental outcome and increase result validity and reliability• Operated in a dynamic environment based on the needs of a growing company and facilitated collaboration with a cross-functional team across engineering, R&D, and bioinformatics • Trained two associates in lab equipment techniques such as the proprietary device, DNA purification process, fluorescence plate reader, waveform generators, electrical switches, voltmeter, and associated software -
Research Associate IiPrognosys Biosciences Jun 2016 - Jul 2017• Spearheaded a data analysis project as the technical lead on the GenePix fluorescent microarray slide imager; Processed up to 40 data reports a week and used statistical software such as Genepix pro7© and Graphpad Prism © to present the resulting data • Extracted data from the Illumina next generation sequencing technology data analysis service (BaseSpace) using R, automated sequencing data clean up, and used statistical analysis to identify insights and conclusions from complex datasets• Reduced costs by making cost-effective decisions in regards to reagent usage and equipment purchases while maintaining or increasing efficiencies• Designed, executed, and troubleshooted spatially encoded multiplex immunohistochemistry assays involving microfluidic devices for new assay development • Independently performed optimization, validation, and orthogonal validation experiments using the Nanodrop, Qubit, PippinPrep, PCR, and qPCR, leading to higher quality data• Used Next Generation Sequencing technologies (MiSeq) to carry out sequencing experiments and analyzed data using NGS data analysis service BaseSpace ©• Advanced departmental projects by carrying out library prep and antibody conjugations involving size exclusion chromatography and validation by HPLC• Managed and trained a lab assistant in lab maintenance SOPs, microfluidic device usage, and electrophoresis resulting in a high-value contributor within 2 months of hire.
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Research Associate IOpthalmic Proteomics Laboratory At Uwg May 2016 - Jun 2016Successfully optimized protein purification procedures resulting in higher quality results, two-fold reduction in time involved, and maximizing use of limited resources.Managed and provided in-depth knowledge to junior research staff Designed and performed experiments, analyzed the resulting data.
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Graduate Student ResearcherUniversity Of West Georgia Aug 2014 - May 2016Carrollton, Georgia, Us• Studying the interaction between lens proteins Aquaporin 0 (water protein channel) and α-crystallin (chaperonin found in high concentration in the lens), in order to shed light on a potential mechanism of cataract formation.• Recruiting, training, and supervising two undergraduate research assistants on various biochemical techniques such as SDS-PAGE, western blots, dot blots, protein purification, and buffer preparation• Conducting protein-protein interaction analysis such as protein purification, immunodetection (western blot/IF/IHC), ligand-binding assays and ELISA. -
Graduate Teaching AssistantUniversity Of West Georgia Aug 2014 - Apr 2016Carrollton, Georgia, Us• Maintained a 4.7/5 feedback score from students over 3 semesters • Assessing student learning via quizzes, homework assignments, and tests etc. and providing effective, timely, and appropriate feedback for 75 to 100 students per semester.• Coordinating and leading study sessions in order to strengthen student understanding of key concepts related to class.Instructing 3-4 classes per semester and supervising 25 students per class.Practicing effective communication with both undergraduate students and department leads• Creating and contributing to the development of teaching materials to meet learning objectives -
Research AssistantUcsd Biochemical Genetics Laboratory Mar 2013 - Mar 2014La Jolla, Ca, Us• Developed an extensive metabolite standards database (700+ chemicals) with minimal supervision to ease the search for chemicals and increase productivity.• Acquired strong troubleshooting, problem solving, and laboratory skills in a CAP-certified laboratory.• Used analytical chemistry to calibrate and validate new HPLC and developing metabolite (i.e. fatty acids, organic acids, amino acids etc.) extraction methods.• Performed & reported test results for all laboratory procedures as assigned, both automated & manual, without immediate review by the director or supervisory team.• Using and maintaining LC-MS/MS, GC/MS, and HPLC machines and associated software: Analyst© and PeakView©.
Leah S. Skills
Leah S. Education Details
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Uc San Diego Extended StudiesData Mining And Advanced Analytics -
University Of West GeorgiaGeneral -
San Diego College Of Continuing EducationProject Management -
Uc San DiegoBiochemistry
Frequently Asked Questions about Leah S.
What company does Leah S. work for?
Leah S. works for Biotrinity Consulting, Llc
What is Leah S.'s role at the current company?
Leah S.'s current role is Clinical Data Management Consultant- Clinical Data Science.
What schools did Leah S. attend?
Leah S. attended Uc San Diego Extended Studies, University Of West Georgia, San Diego College Of Continuing Education, Uc San Diego.
What skills is Leah S. known for?
Leah S. has skills like Artificial Neural Networks, Pandas, Scikit Learn, Support Vector Machine, Spss, Data Science, Algorithms, Bayesian Methods, Western Blotting, Mongodb, Linear Regression, Data Analysis.
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