プロフィール詳細

プロジェクトを作成

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Dr. Omondi E.に依頼

Kenya

Medical writer, Statistician & Data Analyst with 10+ years of experience in clinical research

プロフィール概要

A highly experienced Medical Writer, Statistician, and Data Analyst with 10+ years of expertise in clinical research, biostatistics, and medical writing. Proficient in designing and analyzing clinical trials, epidemiological studies, and healthcare datasets, ensuring compliance with FDA, EMA, and ICH-GCP guidelines. Adept at translating complex scientific data into clear, evidence-based reports, regulatory documents, and manuscripts for high-impact journals. Core Expertise & Skills: ✅ Medical & Scientific Writing – Creation of clinical study reports, systematic reviews, literature reviews, regulatory documents, and manuscripts for peer-reviewed journals. ✅ Statistical Analysis & Data Science – Expertise in SPSS, R, SAS, and Python for hypothesis testing, survival analysis, regression modeling, meta-analysis, and machine learning applications in healthcare. ✅ Clinical Research & Epidemiology – Experience in study design, protocol development, IRB submissions, patient-reported outcomes (PROs), and pharmacovigilance studies. ✅ Data Management & Interpretation – Proficient in handling large healthcare datasets (EHRs, claims data, RWE studies) and deriving meaningful insights. ✅ Regulatory & Compliance – Strong knowledge of FDA, EMA, ICH-GCP, HIPAA, and medical publication standards. Education: 🎓 Master of Science in Biostatistics & Clinical Research Johnston School of Public Health, Hamilton University, New York. 🎓 Bachelor of Science in Biomedical Sciences Westwood University, California. Certifications: 📜 Certified Clinical Research Professional (CCRP) – Association of Clinical Research Professionals (ACRP) 📜 Good Clinical Practice (GCP) Certification – National Institutes of Health (NIH) 📜 SAS Certified Statistical Business Analyst – SAS Institute 📜 Medical Writing Essentials Certification – American Medical Writers Association (AMWA) Research & Project Experience: 🔹 Ongoing & Previous Research Projects: -Conducted meta-analysis on cardiovascular disease risk factors in diverse populations. -Led statistical analysis of oncology clinical trials to assess drug efficacy and survival outcomes. -Developed real-world evidence (RWE) studies using electronic health records (EHRs) and claims data. -Designed and executed pharmacovigilance studies on adverse drug reactions (ADRs) for a multinational pharmaceutical company. -Collaborated on genomics research, applying biostatistical methods to analyze genetic data in precision medicine. Key Achievements: 🏆 Published peer-reviewed articles in medical and scientific journals. 🏆 Assisted biotech and pharmaceutical companies in clinical research and regulatory documentation. 🏆 Provided statistical consulting for academic institutions, healthcare organizations, and contract research organizations (CROs). Industry Sectors: 📌 Pharmaceuticals | Biotechnology | Healthcare | Academic Research | Clinical Trials | Epidemiology | Journal Editing | Product Design | Chemical Engineering.

専門分野

• ☆ Chemical Reagent Development
• ☆ Dewatering & Drying Technology
• ☆ Catalysis
• ☆ Trace Elements
• ☆ Dispersion Chemistry
• ☆ Surface Science
• ☆ Marine Chemistry
• ☆ Inorganic Chemistry
• ☆ Natural Product Chemistry
• ☆ Physical Chemistry
• ☆ Chemoinformatics
• ☆ Biopolymers
• ☆ Polymer Chemistry
• ☆ Electrochemistry
• ☆ Agricultural Chemistry
• ☆ Cosmochemistry
• ☆ Radiochemistry
• ☆ Astrochemistry
• ☆ Petrochemistry
• ☆ Flow Chemistry
• ☆ Green Chemistry
• ☆ Organometallic Chemistry
• ☆ Theoretical Chemistry
• ☆ Evolutionary Biology
• ☆ Biostatistics
• ☆ Zoology
• ☆ Venom
• ☆ Venoms
• ☆ Wildlife Management
• ☆ Wildlife Rehabilitation
• ☆ Cetology
• ☆ Aquatic Mammals
• ☆ Mammalian Biology
• ☆ Equine Studies
• ☆ Cell Biology
• ☆ Cell-Based Assays
• ☆ Membrane Biology
• ☆ Gene Regulation
• ☆ Neuroscience
• ☆ Visual Neuroscience
• ☆ Behavioral Neuroscience
• ☆ Cognitive Neuroscience
• ☆ Neurobiology
• ☆ Systems Neuroscience
• ☆ Mycology
• ☆ Sociobiology
• ☆ Comparative Physiology
• ☆ Marine Biology
• ☆ Biophysics
• ☆ Agronomy & Crop Science
• ☆ Soil Science
• ☆ Aviation
• ☆ Data Analysis
• ☆ Data Collection
• ☆ Business Analytics
• ☆ Statistics
• ☆ Applied Statistics
• ☆ Cell Culture
• ☆ Primary Cells
• ☆ Cell Banking
• ☆ Cell Surface Receptors
• ☆ Knowledge Management
• ☆ Taxonomy/Classification
• ☆ Forensic Entomology
• ☆ Forensic Genetics
• ☆ Information & Knowledge Management
• ☆ Data Storage
• ☆ Human Behavior & Psychology
• ☆ Sports Psychology
• ☆ Cognitive Science
• ☆ Clinical Psychology
• ☆ Health Psychology
• ☆ Military Psychology
• ☆ Political Psychology
• ☆ Religious Psychology
• ☆ Forensic Psychology
• ☆ Behavioral Genetics
• ☆ Child & Adolescent Psychology
• ☆ Family Psychology
• ☆ Developmental Psychology
• ☆ Applied Psychology
• ☆ Organizational Studies
• ☆ Learning & Memory
• ☆ Educational Psychology
• ☆ Analytical Psychology
• ☆ Human-Computer Interactions (HCI)
• ☆ Design Thinking
• ☆ Personality Analysis
• ☆ Child Development
• ☆ Social Psychology
• ☆ Visual Perception
• ☆ Psychology of Creativity
• ☆ Positive Psychology
• ☆ Biological Anthropology
• ☆ Linguistic Anthropology
• ☆ Medical Anthropology
• ☆ Social Movements
• ☆ Environmentalism
• ☆ Demography
• ☆ Human Migration
• ☆ Linguistics
• ☆ Semantics
• ☆ English Language
• ☆ Foreign Language Learning
• ☆ Computational Linguistics
• ☆ Speech-Language Pathology
• ☆ Diplomacy & International Relations
• ☆ Local Politics & Government
• ☆ Political Science
• ☆ Political Theory
• ☆ Geopolitics
• ☆ Terrorism, Insurgency & Political Violence
• ☆ Military Technology
• ☆ Military Policy
• ☆ Warfare
• ☆ Military History
• ☆ Military Logistics
• ☆ Veteran Studies
• ☆ Postcolonial Studies
• ☆ Political Systems & Philosophies
• ☆ Health Policy
• ☆ Public Policy Administration
• ☆ Land Use Planning
• ☆ Cultural Policy
• ☆ State Policy & Legislation
• ☆ Housing & Housing Policy
• ☆ Economic Policy
• ☆ Development Economics
• ☆ Education Policy
• ☆ Humanitarian Aid
• ☆ Public Finance
• ☆ Urban Planning
• ☆ Clinical Social Work
• ☆ Adoption
• ☆ Social Welfare
• ☆ Human Services
• ☆ Social Work
• ☆ Gender Equality
• ☆ Human Rights
• ☆ Telecommunications
• ☆ Internet
• ☆ English as a Second Language (ESL)
• ☆ English Studies
• ☆ Multilingualism
• ☆ Semiotics
• ☆ Cognitive Linguistics
• ☆ Political Campaigns
• ☆ Justice Systems
• ☆ Abnormal Psychology
• ☆ Cyberpsychology
• ☆ Sensory Studies
• ☆ Identity
• ☆ Child Psychology
• ☆ Emissions Trading
• ☆ Community Development
• ☆ Child & Adolescent Welfare
• ☆ Violence Prevention
• ☆ Child & Adolescent Social Work
• ☆ Indigenous Languages
• ☆ Spanish
• ☆ Italian
• ☆ Asian Languages
• ☆ Arms & Defense
• ☆ Naval History & Science
• ☆ Military Life
• ☆ Investigations & Intelligence
• ☆ Democracy
• ☆ Agrarianism
• ☆ Conservatism
• ☆ European Politics & Government
• ☆ United States Politics & Government
• ☆ Parapsychology
• ☆ Nationalism
• ☆ SAS
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Clinical Pharmacy
• ☆ Drug Discovery
• ☆ High Throughput Screening (HTS)
• ☆ Drug Target Identification
• ☆ Hit-to-Lead & Lead Optimization
• ☆ Phenotypic Assays
• ☆ High Content Screening/Imaging
• ☆ Medicinal Chemistry
• ☆ Drug Design
• ☆ Combinatorial Chemistry
• ☆ Structure-Activity Relationship (SAR) Studies
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Allergy & Clinical Immunology
• ☆ Clinical Immunology
• ☆ Anesthesiology
• ☆ Dermatology
• ☆ Dermatologic Surgery
• ☆ Skin Cancer
• ☆ Primary Care/Family Medicine
• ☆ Human Biology
• ☆ Sleep Medicine
• ☆ Teratology/Birth Defects
• ☆ Orthoptics
• ☆ Kinesiology & Exercise Science
• ☆ Preventive Medicine
• ☆ Precision Medicine
• ☆ General Surgery
• ☆ Abortion
• ☆ Dentistry
• ☆ Dental Research
• ☆ Orthopedic Surgery
• ☆ Plastic Surgery
• ☆ Oral & Maxillofacial Surgery
• ☆ Podiatry
• ☆ Hospice & Palliative Medicine
• ☆ Pain Management
• ☆ Cardiac Surgery
• ☆ Public Health
• ☆ Dietetics
• ☆ Medical Toxicology
• ☆ Health Informatics
• ☆ Traditional Medicine
• ☆ Intensive Care Medicine
• ☆ Photodermatology
• ☆ Dermatitis
• ☆ Audiology
• ☆ Photomedicine/Phototherapy
• ☆ Internal Medicine
• ☆ Zoonoses
• ☆ Back & Spine Health
• ☆ Environmental Medicine
• ☆ Geriatric Medicine
• ☆ Military Medicine
• ☆ Perinatology
• ☆ Travel Medicine
• ☆ Pediatric Surgery
• ☆ Trauma Surgery
• ☆ Craniofacial Surgery
• ☆ Vascular Surgery
• ☆ Developmental Disabilities
• ☆ Blindness & Visual Impairment
• ☆ Physical Disabilities
• ☆ Medical Terminology
• ☆ Medical Sciences
• ☆ Connective Tissue
• ☆ Vision Health
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Medical Equipment & Supplies
• ☆ Laparoscopic/Minimally Invasive Surgery
• ☆ Laser Surgery
• ☆ Medical Writing
• ☆ SEO Medical Writing
• ☆ Small Business
• ☆ Medical Law
• ☆ International Law

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, Newswriting, Audio Transcription, General Proofreading & Editing, Translation

Research Market Research, User Research, Feasibility Study, Technology Scouting, Fact Checking, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Digital Strategy Consulting, Healthcare Consulting, Legal Consulting, Scientific and Technical Consulting, Manufacturing Consulting

Data & AI Statistical Analysis, Data Visualization, Data Mining, Data Cleaning, Data Processing

Product Development Recipe Development, Deformulation, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Product Launch Support, Packaging Design, Prototyping, Device Fabrication

職務経験

Bright Cloud International (United States)

- 現在

Bright Cloud International (United States)

8月 2022 - 現在

学歴

Master of Science in Biostatistics & Clinical Research (Biostatistics & Clinical Research)

Colorado School of Public Health

1月 2011 - 4月 2013

Bachelor of Science in Biomedical Sciences (Science in Biomedical Sciences)

California Western University

9月 2007 - 8月 2011

認定資格

• Certified Clinical Research Professional (CCRP)

  Association of Clinical Research Professionals (ACRP)

  3月 2015 - 現在

• SAS Certified Statistical Business Analyst

  SAS Institute

  1月 2016 - 12月 2025

• Medical Writing Essentials Certification

  American Medical Writers Association (AMWA)

  7月 2017 - 11月 2025

• Good Clinical Practice (GCP) Certification

  National Institutes of Health (NIH)

  8月 2023 - 8月 2025

出版物

CONFERENCE PAPER

Improvement of n-type nc-3C-SiC:H heterojunction emitter for c-Si solar cells @inproceedings{Shimizu_2014, title={Improvement of n-type nc-3C-SiC:H heterojunction emitter for c-Si solar cells}, url={http://dx.doi.org/10.1109/pvsc.2014.6925142}, DOI={10.1109/pvsc.2014.6925142}, booktitle={2014 IEEE 40th Photovoltaic Specialist Conference (PVSC)}, publisher={IEEE}, author={Shimizu, Kazuki and Ateto Eric Omondi and Irikawa, Junpei and Miyajima, Shinsuke and Konagai, Makoto}, year={2014}, month=jun, pages={1253–1256} } . 2014 IEEE 40th Photovoltaic Specialist Conference (PVSC).

JOURNAL ARTICLE

erick Phytoremediation of Polychlorobiphenyls (PCB’s) in Landfill E-Waste Leachate with Water Hyacinth (E.Crassipes).