Feba Varghese

About Feba Varghese

Biostatistician with 8 years of experience in designing and analyzing clinical trials to support global drug development and regulatory submissions. Skilled in developing statistical analysis plans (SAPs), programming in SAS/R, and generating high-quality tables, listings, and figures (TLFs) to deliver reliable insights. Experienced in study design, sample size estimation, and randomization planning, with a strong track record of ensuring compliance with ICH-GCP and FDA/EMA guidelines. Also, Experience in real-world data (RWD) analytics, biostatistics, and observational research within the pharmaceutical and healthcare domain. Proven expertise in designing and executing advanced statistical analyses to generate real-world evidence (RWE) supporting clinical development, regulatory submissions, and market access strategies. Experienced in serving as the primary statistical point of contact for cross-functional stakeholders and external partners. Demonstrated expertise in overseeing and managing CRO deliverables, including statistical analysis plans (SAPs), programming outputs, TLF validation, timelines, and quality compliance to ensure alignment with internal standards and regulatory expectations.Strong experience collaborating with cross-functional teams including clinical, epidemiology, data management, regulatory, and global stakeholders. Delivering high-quality statistical outputs, mentoring junior statisticians, driving methodological innovation, and ensuring compliance with industry standards and regulatory guidelines. Adept at translating complex statistical findings into clear, actionable insights for scientific and business audiences.

Experience

1. Senior Statistician

   Novo Nordisk

   Aug 2024 — Present · Bengaluru, IN

Education

• Mar Thoma College, Kuttapuzha P.O. Tiruvalla, Pathanamthitta- 689103

  Bachelor of Science (BSc), Mathematics

  2012 — 2015

• St Thomas College, Palai

  Master of Science, Biostatistics

  2015 — 2017