Shikha Sreshtha

About Shikha Sreshtha

Shikha is a statistical programming lead with extensive experience in clinical trial data analysis, reporting, and regulatory submissions. She currently works at Johnson & Johnson, where she leads programming activities in oncology studies, ensuring high-quality deliverables and efficient, standards-driven processes.Her background spans more than a decade across pharma and CROs, where she managed large teams, built reusable programming frameworks, and supported studies across therapeutic areas such as oncology, cardiovascular disease, rare diseases, arthritis, Parkinson’s, and mental health. She brings with her strong experience in Real World Evidence (RWE/Registry Studies) leading global teams to deliver on ambitious drug effectiveness/safety goals.Shikha is passionate about applying innovative programming approaches, mentoring teams, and strengthening clinical reporting processes to support impactful drug development.

Experience

1. Sr i Stat Prog Lead

   Johnson & Johnson

   Jan 2025 — Present · Hyderabad, IN

   Currently leading statistical programming activities in the oncology therapeutic area, with a focus on driving high-quality clinical trial deliverables. My role involves:• Planning, strategy, coordination, and execution of programming activities across multiple trials and projects in line with J&J and industry standards• Designing and developing programs to support complex clinical data analysis and reporting• Leading submission activities, including the creation, validation, and delivery of CDISC-compliant and other data packages along with reviewer’s guides• Providing technical and project-specific guidance to team members, ensuring efficiency, quality, and timely delivery of outputs• Driving adoption of the latest programming standards, metadata-driven approaches, and innovative tools to improve processes• Collaborating with cross-functional teams and external vendors to achieve project milestones• Supporting departmental initiatives by contributing to process improvements, tool enhancements, and system implementations

Education

• Indian Institute of Management, Lucknow

  Executive Program in Data Science, Data Science

• DY Patil University

  Master’s Degree, Biotechnology

  2010 — 2012

• Bundelkhand University

  Bachelor’s Degree, Biotechnology

  2005 — 2009

Skills

• Molecular Biology
• Sas Programming
• Research
• Sds-Page
• Cell Culture
• Lifesciences
• Immunology
• Life Sciences
• Microsoft Office
• Animal Cell Culture
• Vlookup
• Polymerase Chain Reaction (Pcr)
• Pcr
• R
• Sas Base
• Biotechnology
• Microsoft Excel
• Powerpoint
• Microbiology
• Sas
• Dna Extraction
• Validation
• Ms Excel Pivot Tables
• High Throughput Screening
• Statistics