Amulya Bista

About Amulya Bista

Extensive experience leading global oncology submissions (BLA/MAA) and modernizing clinical data infrastructure. Expert in bridging the gap between traditional CDISC standards and next-generation technologies, having successfully established validated R/Python computing environments and internal SaaS dashboarding platforms. Proven track record of driving cost efficiencies, conducting technical briefings with the FDA on CRT packages and submission documentation, and executing technical due diligence for business growth.Additionally, I have experience in preparing Integrated Summaries of Safety and Efficacy (ISS and ISE) for submission, as well as creating datasets for PK/PD and biomarker analysis. My skills include data analysis, statistical analysis, generating safety and efficacy tables, listings, and graphs using SAS programming, such as BASE SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS.I have also created analytical applications using R Shiny and SAS and managed consultants and CRO resources for various projects. With my expertise in statistical analysis plans and protocol development, I can provide additional insight into the analysis of clinical trials. I am knowledgeable about ICH/GCP and 21 CFR Part 11 regulations and experienced in leading periodic submissions such as Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), and Investigator Brochures (IB).In addition, I have successfully created and deployed R/Shiny visual analytical interactive dashboards, and I have an understanding of different graphic programming procedures such as graphics template language to produce forest plots, scatter plots, line plots, Kaplan-Meier plots, box plots, bar charts, eDISH plots, and waterfall plots. I am capable of creating and maintaining validated SAS servers, and I am experienced with handling various post-marketing requirements from FDA and EU.

Experience

1. Senior Director, Statistical Programming

   Summit Therapeutics, Inc.

   Oct 2025 — Present · Palo Alto, CA, US

   Strategic Leadership & Regulatory OversightOversaw the end-to-end statistical programming portfolio for multiple indications from study initiation through successful BLA/MAA submissions, serving as the primary decision-maker for data strategy.Led regulatory defense strategies for global health authorities, directly managing responses to complex FDA and EMA Information Requests (IR) to ensure expedited approval timelines.Executed technical due diligence for potential asset acquisitions and partnerships, evaluating data integrity, systems compatibility, and compliance risks to inform executive-level business development decisions.Infrastructure & Computing Environment (SCE)Spearheaded the enterprise-wide establishment of a modern Statistical Computing Environment (SCE), defining the roadmap for a production system for R and a flexible development environment for Python.Modernized the department’s technical stack, moving beyond legacy SAS workflows to integrate open-source languages (R/Python), ensuring scalability for future clinical data science needs.Innovation, Tool Development & ROIArchitected and deployed a proprietary R/Shiny/Python Dashboard Publishing Platform, internally developing a solution that replaced costly external vendors, saving the company hundreds of thousands of dollars annually while streamlining the publishing lifecycle.Championed the development of an in-house Interactive Patient Profile Dashboard, providing Medical Monitors and Safety Physicians with real-time visualization tools to enhance subject safety reviews and data decision-making.

Education

• Bryn Athyn College

  Bachelor of Arts (B.A.), Mathematics and Physical Science

  2008 — 2012

• Xavier International College

  A Level, Math and Physics

  2006 — 2008

Skills

• Windows Server
• Visual C#
• Hardware Installation
• Sas
• Microsoft Office 2003
• Html 5
• Edc
• Office 2010
• Photoshop
• Sas Programming
• Statistics
• Mysql
• Linux
• Sdtm
• Maple
• R
• Cdisc
• 21 Cfr Part 11
• Java
• C++
• SEO
• Microsoft Office
• Microsoft Office 2007
• Statistical Data Analysis
• Clinical Data Management
• Adam
• Windows Vista
• Php
• Clinical Trials
• Html
• Software Installation
• Statistical Programming
• Minitab
• Oncology
• Sas Base
• Biostatistics
• Matlab
• Windows 7
• Pharmaceutical Industry
• E-Commerce