Budhaditya Goswami

About Budhaditya Goswami

Target oriented professional with 10 years of experience as Biostatistician in clinical research in early phase, late phase and expertise in real world evidence. Other interests: Enriching scope of drug development using machine learning and artificial intelligence.Providing input to study design, protocol development, analysis plan - shell development, CSR writing. Development of submission quality documents like briefing book, FDA/ EMA filing plan ( ISS, USPI, SmPC), extensive support in HA request. End to end submission experience in development and submission of safety package for Tafasitamab (2nd Line DLBCL approved in US market 2020).Area of expertise(Biostatistics)Real world evidence - Propensity Score Matching and other robust covariate adjustment techniques, bayesian dose escalation designs, group sequential design, dose finding, basket trials, graphical approaches to missing data, Promising zone designs, PK-PD, Proof-Of-Concept, Design of Experiment( Parallel and Crossover studies)Disease area experience:Oncology - Solid tumours, Diffused Large B-cell LymphomaGeneral Medicine - Neuroscience - Multiple Sclerosis, Sleep Study, Autism Spectrum disorder, Musculoskeletal - Sarcopenia, Malaria StudiesNeuro science - Multiple sclerosis, Autism Inflammatory Diseases: Ulcerative Colitis, Crohn\'s DiseaseData Standards: Working experience in SDTM, ADAM and TDM data modulesArea of expertise (Machine learning/ Artificial intelligence):Masters Thesis: Automated counting of blood cells from microscopic smear images using object detection models (YOLOv3)- Project1: Attention network for image captioning- Project2: Identification of Pneumonia from chest X rays using image networks- Project3: Skin cancer detection using transfer learning models- Project4: Identifications of common topics from online reviews - Project5: Early defaulter detection in prepaid network service through ML models Programming Languages KnownSAS, R, Python, SQLOther: R-Shiny, Flask, Markdown, Latex

Experience

1. Sr Manager (People Manager)

   화이자

   Apr 2025 — Present · Chennai, IN

   Statistical Leadership: IIM certified leader managing group of statisticians, responsible for their operational and technical growth.Individual Contribution: Trial Statistician (50%): Lead statistician for design and development of I&I clinical trial, including cross functional collaboration, CDP, USPI-SMP, health authority interactionConsultancy (50%): Statistical methodology consultancy to internal functions - Bayesian dose escalation designs, IA planning, trial emulation, ML based Multiple ComparisonProficient in SAS, R and Python. Developed applications based on Rshiny, Python Streamlit including deployment in AWS

Education

• Calcutta University, Kolkata

  Bachelor of Science - BS

  2008 — 2011

• Liverpool John Moores University

  Master in ML and AI

• Liverpool John Moores University

  Master of Science - MS

• Indian Statistical Institute, Kolkata

  Master of Science - MS

• Indian Statistical Institute, Kolkata

  M.STAT(Master of Statistics)

  2011 — 2013

Skills

• Simulations
• Research
• Data Analysis
• Biostatistics
• Clinical Trials
• Modeling
• Exploratory Data Analysis and Machine Learning
• R
• Sdtm
• Sas
• Statistical Modeling
• C
• Clinical Research
• Analysis
• Statistics