Biswajit Kumar

About Biswajit Kumar

As a trained data scientist and biotechnologist, I specialize in leveraging the transformative power of data to drive scientific discoveries. With over 18+ years of dynamic experience in the healthcare industry, I\'ve garnered a sterling reputation as a versatile, hands-on techno-functional leader, with an exemplary proficiency in data science, Clinical data operations, stats and programming, Real World Evidence, RPA and Six Sigma methodologies.Fueled by my deep understanding of clinical data operations, statistics, and programming, I also carry a keen interest in data exploration. I leverage top-tier tools like R Shiny and Python to parse through complex data networks, unearthing crucial insights that power decisive clinical advancements.My tenure is marked with leading a large global team across multitude of projects, successfully translating intricate business needs into inventive strategies that have consistently yielded notable results. My expertise includes overseeing an array of innovative submission and non-submission trials, such as interventional, non-interventional studies, Real-World Evidence (RWE), and health economics and outcome research (HEOR), where I handle everything from concept design to data acquisition and analysis strategies.At the heart of my prowess lies my ground-breaking work in data linkage through tokenization. By binding data from diverse sources, I\'ve been able to generate an encompassing and comprehensive view of patient health journeys, thus accelerating evidence generation.As a passionate advocate for technology, I\'m dedicated to improving patient outcomes and driving healthcare innovation. My portfolio includes the successful implementation of purpose-fit digital health solutions such as wearables and sensors and leading the charge in adopting electronic clinical outcome assessments (eCOA).I bring with me a wealth of experience, passion, and a deep commitment to using data science as a catalyst for innovative advancements in healthcare for the patients.

Experience

1. Head -clinical Data Operations and Analytics

   Novartis

   Oct 2020 — Present · US

   Providing leadership to data analytics and data Operations (Clinical data Management, Database development and reporting, Clinical standards,medical coding,stats programming ) group across Therapeutics areas and HEOR.2.Establish and Lead Data Insights and Analytics CoE. Responsibilities include but not limited to develop and execute innovations like R-shiny apps, application of machine learning models in Clinical and Real-World Data. Developed and operationalized analytical dashboards translating medical questions into actionable insights and analytics directly improving the trial effectiveness 3.Provide functional and operational leadership to data management, database operations, statistical programming, and data analytics groups across all Therapeutic Areas. Accountable for people and budget.4. Lead to establish first in class agile and ethical methodologies for various fit for purpose data and digital strategies in clinical trials e.g, eCOA, Patient Recruitment, wearables and sensors, SaaS technologies, virtual trials, Decentralized Trials (DCTs), Patient Engagement, De-Identification, and tokenization for EHR/CLAIMS data)5. Responsible to manage and track budget, KPIs, Data and Digital projects.

Education

• National Institute of Business (NIBM) Unit of Kingston University

  Executive MBA, International Business

• Symbiosis Institute of Business Management, Pune

  PGDBA, Operation Management

• University of Michigan - School of Information

  Masters, Applied Data Science

• Kendriya Vidyalaya (IIT-ISM)

  Higher secondary

• Bangalore University

  MSc in Biotechnology

• Indian Institute of Management, Calcutta

  Executive Program in Business Analytics, Analytics

Skills

• Analysis
• Pl/Sql
• Meddra
• Clinical Data Management
• Cdisc
• Data Standards
• Oracle Clinical
• Sql
• Sdtm
• 21 Cfr Part 11
• Programming
• Clinical Trials
• Crf Design
• Research
• Clinical Study Design
• Sas
• Clinical Research
• Oc Rdc
• U.s. Title 21 Cfr Part 11 Regulation
• Business Analysis
• Process Improvement
• Clinical Data
• Database Design
• Drug Development
• Good Clinical Practice (Gcp)
• Gcp
• Ich-Gcp
• Edc
• Therapeutic Areas
• Pharmaceutical Industry
• Data Management
• Validation
• Cdisc Standards
• Strategy
• Electronic Data Capture (Edc)
• Testing
• Training