Pragnya Mishra

About Pragnya Mishra

Experienced in statistical programming in the clinical domain. Thorough understanding of clinical trial processes, from data collection to analysis reporting for regulatory submissions. Experienced in functioning as programming lead for early phase and late phase studies with team members dispersed globally. Excellent written and oral communication skills. Ability to think logically and work independently or within a team.Key Skills: Skilled in SAS/BASE, SAS/Macros, SAS/SQL and SAS/Report Thorough understanding of CDISC standards and the ADaM implementation guide. Skilled in creating ADaM datasets, writing ADaM reviewer’s guide(ADRG) and creating define XML as a part of CRT package. Development of SAS programs/utilization of SAS Macros to create/QC SAS datasets and produce/validate tables, listings and figures. Contributed effectively towards FDA and EMA submissions. Efficiently perform the role of a Lead Programmer: delegation of tasks, overseeing the programming activities, providing technical guidance and active communication across the study team including the Statisticians, Data Management and Clinicians. Good presentation and training skills. Experienced in conducting training sessions for employee development and capability building. Detail oriented, proactive and self-motivated.

Experience

1. Senior Manager - Programming (Oncology India Disease Area Lead)

   GSK

   Apr 2025 — Present · Bengaluru, IN

Education

• Institute of Bioinformatics and Applied Biotechnology (IBAB)

  Master’s Degree, Bioinformatics and Biotechnology

  2013 — 2015

• Fergusson College

  Bachelor’s Degree, Biotechnology

  2010 — 2013