Jitendra Singh

About Jitendra Singh

Strong knowledge involving all phases (I-IV) of clinical trials.Extensively involved in clinical data analysis and preparation of SAS Data sets, Reports, Tables, Listings, Summaries and Graphs according to the Statistical Analysis Plan.Good experience in SAS/R on Windows environment.Proficient in Macro Facility, SAS Procedures, SAS formats, SAS functions, SAS statements, SAS Informats, Merging SAS Data sets, preparing data, producing reports, storing and managing data in SAS.Good in modifying existing SAS programs and creating new programs using SAS macro variables to improve ease and speed of modification as well as consistency of results.Proficient in working with SDTM, ADaMs using CDISC standards. Worked on HA (FDA, EMA, PMDA) Question and Answers.Involved in the process of generating PRS (Project Reports Specifications), TLG’s (Tables, Listings and Graphs) for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.Good understanding of clinical protocols/ CRF’s/Annotated CRF’s, ICH and GCP guidelines, NDA, IND, CDISC, MedDRA, 21 CFR PART 11.Have excellent analytical, problem solving, communication and interpersonal skills, with ability to interact with individuals at all levels of the organization and contributing to project success in multi-tasking, fast-paced environment.

Experience

1. Principal Statistical Programmer

   IQVIA

   Aug 2022 — Present · Lucknow, IN

Education

• St Joseph's University

  BS, Life Science(MICROBIOLOGY,CHEMISTRY,ZOOLOGY)

  2005 — 2008

• Sri Ramachandra Institute Of Higher Education and Research

  MS, Bioinformatics(Bio-statistics)

  2008 — 2010