Clinical Research Data Science
Resume:
Amarnadh Oleti
Senior Clinical Data Scientist
********.*****@*******.*** • 405-***-****
Stillwater, OK 74075 • LinkedIn
Seasoned, analytical, and solutions-oriented professional with proven expertise in SAS programming and statistical analysis for clinical research, offering a track record of leading overall statistical aspects of large-scale, multicenter clinical trials. Proficient in advanced statistical techniques, including inferential statistics, ANOVA, t-tests, chi-square tests, and regression analysis for comprehensive data analysis. Demonstrated excellence in managing diverse statistical projects, from multicenter clinical trials to observational studies, adhering to SOPs, SAP, SDTMIG, and ADaM guidelines. Skilled in developing datasets, tables, figures, listings (TFL’s) and reports, particularly for studies related to infectious diseases, chronic conditions, oncology and dermatological disorders. Committed to ensuring data integrity and adherence to clinical and regulatory standards, leveraging advanced statistical tools to drive insights and advancements in therapeutic approaches.
Technical Proficiencies
Statistical Analysis: Univariate & Multivariate Analysis, Predictive Modeling (Linear, Logistic Regression, Multiple Regression), and Multi-level Models.
Machine Learning: Supervised & Unsupervised Learning, Bayesian Methods, Naïve Bayes Analysis, K-means Clustering and Segmentation, Decision Trees, Ensemble learning, XGBoost models, Support Vector Machines. Deep Learning: Artificial Neural Networks, Convolutional Neural Networks, and Recurrent Neural Networks. Data Standards & Validation: aCRF, Data validation, FDA, ICH GCP guidelines, CDISC (SDTM & ADaM), Protocol Compliance Programming Languages & Tools: Python, R, SAS Viya, SAS/BASE, SAS/STAT, SAS/GRAPH, SAS /MACROS Databases & Cloud Computing: SQL, and MongoDB, Spark, Google Cloud Platform Areas of Expertise
Clinical Trials (Phase-1 to Phase-4)
Clinical Data Management
Oncology studies
Descriptive Statistical Analysis
SOP & SAP Compliance
CTCAE & HIPAA
Safety and Efficacy Reports
Data Visualization
Multidisciplinary Team Collaboration
Professional Experience
Data Scientist Dept. of Plant and Soil Science, Oklahoma State University, Stillwater, OK May 2024 – Present Developed and defined research variables to align with scientific objectives, utilizing advanced formulas and computational algorithms to generate insightful derived variables and indices for enhanced data analysis. Wheat Grain Yield Response to Nitrogen, Phosphorus, and Potassium Fertilization under Irrigation: Streamlined organization of six decades of agricultural research data, enforcing strict standards for data formatting, naming conventions, and documentation to enhance consistency and accessibility across studies. Rectified inconsistencies and errors within research datasets; reformed data formats, eradicated duplicate entries, and conducted rigorous quality assessments to refine data for advanced analytical processes. Graduate Research Assistant Dept. of Plant and Soil Science, Oklahoma State University, Stillwater, OK July 2023 – April 2024 Provide technical support to undergraduate students working on related projects, enhancing educational outcomes and research productivity. Participate in preparation of research papers, reports, and presentations for dissemination at academic conferences. Weed Plant Lifecycle Analysis Under Elevated Temperatures: Advanced statistical models analyzed lifecycle of Foxtail and Palmer Amaranth, leading to predictive insights for enhanced weed management and agricultural practices under climate variations. Data Scientist Arbot Analytics, Chennai, India April 2020 – March 2022 Developed custom data models and algorithms to apply to data sets, using statistical, machine learning, or deep learning techniques. Utilized data visualization tools to present data insights to management and stakeholders effectively. Breast Cancer Diagnostics Using Machine Learning: Developed statistical models that distinguished between benign and malignant breast cancer with 95% accuracy rate, improving early diagnostic interventions. E-Commerce Customer Lifetime Value Prediction: Utilized historical data and machine learning to predict customer lifetime value, boosting repeat customer rates by 25%.
Business Data Analyst Arbot Analytics, Chennai, India June 2017 – March 2020 Developed and deployed interactive dashboards and reports using data visualization tools like Tableau, Power BI, or similar platforms. Implemented data governance policies to ensure data security, privacy, and compliance with industry standards and regulations. Consumer Behavior Analysis in Retail: Tailored marketing strategies increased customer engagement by 20%, analyzing consumer buying trends. Page 2 2
Hospitality Industry Sentiment Analysis: Employed NLP to analyze customer feedback, improving service quality and increasing satisfaction scores by 10 points.
Retail Chain Supply Chain Optimization: Advanced data analytics initiatives reduced logistics expenses by 20% and enhanced delivery times by 30%.
Manufacturing Process Optimization: Data-driven strategies improved production efficiency by 15% and reduced costs by 10%. Fraud Detection in Financial Institutions: Developed a detection system that reduced fraudulent transactions by 40% using business intelligence tools.
Sr. Statistical Programmer Kalvin Techsol Private Limited, Hyderabad, India January 2015 – April 2017 Created and maintained detailed documentation of programming activities, including specifications, validation plans, and program code. Performed quality control checks on statistical output to ensure accuracy and consistency with study specifications. Pediatric Hypophosphatasia Study (ENB-0040): Detailed safety and efficacy reports supported using comprehensive data visualization and adherence to standard operating procedures.
ATTR Cardiomyopathy Study (ALXN2060 in Japan): Compiled rigorous safety and efficacy reports for regulatory submission, emphasizing data integrity and adherence to protocols.
COVID-19 Clinical Study (EB05 + SOC vs. Placebo + SOC): Optimized data analysis for a critical study, enhancing research accuracy and supporting strategic clinical decisions.
Diabetic Kidney Disease Drug Trial: Led Phase 2 trial, providing crucial insights for therapeutic strategies, adhering to strict data standards. Colorectal Cancer Study (Bevacizumab): Employed survival analysis and statistical methods to compare treatment efficacy and safety in a Phase III trial.
Prostate Cancer Safety Evaluation (Firmagon®): Coordinated multicenter trials in India, enhancing data collection and safety evaluations. Psoriasis Drug Trial (AUR101): Led Phase II trial assessing treatment efficacy in severe conditions, maintaining rigorous evaluation protocols. Jr. Statistical programmer Kalvin Techsol Private Limited, Hyderabad, India January 2013 – December 2014 Assisted in development, testing, and implementation of statistical software and programs. Executed and managed programming tasks related to clinical trial data, including data cleaning, data integration, and data reporting. Atopic Dermatitis Observational Study (Elidel® in China): Standardized data collection and analysis to adhere to study requirements and enhance integrity.
Allergic Contact Dermatitis Study (EB01 Cream): Managed data processes for a vehicle-controlled trial, focusing on safety and efficacy. Cirrhosis Treatment Study: Led Phase 2 study assessing treatment for refractory ascites, ensuring adherence to clinical standards. Malaria Medication Study: Implemented a Phase I study, validating data sets and statistical outputs to enhance treatment reliability. Migraine Treatment Observational Study: Supported high-impact analysis of combination drug efficacy, adhering to rigorous standards and ensuring data integrity.
Additional Experience
Veterinary Service Officer (Sales & Marketing), Pfizer Animal Health India Limited, Hyderabad, India Clinical Research Coordinator – Internship at Macrokare (CRO), Hyderabad, India Case Competition / Academic Projects
Wharton People Analytics Case Competition Oklahoma State University, February 2024 – Present Humana Mays Health Care Analytics Case Competition Oklahoma State University, August 2023 – December 2023 Water Supply Forecast Rodeo: Development Arena Analytics Case Competition Oklahoma State University, August 2023 – December 2023 Customer and Retail Business Analytics Client: Home Depot Oklahoma State University, September 2022 – May 2023 Clinical Data Analytics Accessing Safety & Efficacy of Test Drug (Phase-II) Oklahoma State University, January 2023 – May 2023 Education
Master of Science in Business Analytics & Data Science Spears School of Business Oklahoma State University, May 2024 Post Graduate Diploma in Clinical Trials Research Institute of Clinical Research India (ICRI), 2011 Master of Business Administration (Health Care Service) Sikkim Manipal University, India, 2010 Master of Science in Microbiology & Molecular Biology Acharya Nagarjuna University, India, 2009 Certifications
ACAP (Associated Certified Analytics professional) SAS Certified Specialist Base programming using 9.4. SAS Certified Professional: Advanced Programming Using SAS 9.4Tableau Desktop Specialist Power BI Data Analyst Associate
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