Raj Kumar Agrawal

About Raj Kumar Agrawal

More than 10 years of experience in statistical programming in Oncology, Gene and Cell Therapy, Cardiovascular and HIV therapeutic areas. Thorough understanding of clinical trial processes, from data collection to analysis reporting for regulatory submissions. Experienced in functioning as programming lead for early 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 & R programming. Thorough understanding of CDISC standards and the SDTM, ADaM Implementation guide. Skilled in creating ADaM datasets, writing ADaM reviewer’s guide (ADRG) and creating define XML as a part of CRT package. Skilled in annotating CRF\'s, creating SDTM Specifications & SDTM datasets. 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. Responsible, resourceful, detail oriented, proactive, self-motivated and reliable individual and team worker with leadership experience and skills.

Experience

1. Senior Statistical Programmer Ii

   ICON plc

   Oct 2023 — Present · Mumbai, IN

   Working effectively on multiple projects delivering quality outputs in a timely fashion. Programs aCRF, SDTM Spec, SDTM Datasets, ADAM Datasets, listings and tables without supervision and advice to others within the team. Able to work on complex programming assignments and share knowledge appropriately. Attending project team meetings, as required, and currently started leading couple of studies. 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. Hiring Talent across PAN India.

Education

• Bangalore University

  Master of Science - MS, Biotechnology

• Salwan Boys School

  Science with maths, Biology, General

  2006 — 2008

• Garden City College Bangalore

  Bachelor's degree, Biochemistry, Biotechnology, Genetics

• Modern Indian School

  10th, All subjects

  1996 — 2006