Kiran H

About Kiran H

Proficient in leading both early and late phase studies.Experienced in clinical trial data analysis and reporting in CDISC standards.Therapeutic areas include haematology, immunology, muscle dystrophy (rare disease) and oncology. QTC studies. DSUR reports and BIMO listings.Narratives, ISS, POP PK analysis, SCE/SCS, Benifit risk analysis and NONMEM dataset & Biomarkers. Efficacy, study pop and safety TLF’sSAS macros and PKPD, efficacy graphs development. Assisting CSR reports.CRF review.CRT package ( Define, ADRG and ARM), P21SDTM review, ADaM datasets and specs development.EUDRA CT, IND Submission reports.Resource planning and alignment.CFR Part 11, ICH GCP guidelines.

Experience

1. Principal Statistical Programmer

   Cytel

   Nov 2024 — Present · Bengaluru, IN

Education

• SAPTHAGIRI COLLEGE OF ENGINEERING

  Bachelor of Engineering (B.E.), Biotechnology

  2008 — 2012

• S. Nijalingappa pu collge

  Pre-university(PU), Science

  2006 — 2008

• Apollo High School

  S.S.L.C; S.E.E.B

  1999 — 2006

Skills

• Microsoft Excel
• R Graphical Interface
• Sas/Sql
• Clinical Research
• Data Management
• CRO
• Fermentation
• Protocol
• Edc
• 21 Cfr Part 11
• Excel Dashboards
• R Studio
• Sas
• CRO Management
• Sas/Macros
• Sop
• Biostatistics
• Validation
• Cdisc Standards
• Visual Basic for Applications (Vba)
• Clinical Development
• Upstream Processing
• Clinical Study Design
• Sdtm
• Pharmacokinetics
• Good Clinical Practice (Gcp)
• Visual Basic
• Ich-Gcp
• Sas Programming
• Biotechnology
• Gcp
• Biopharmaceuticals
• Pl/Sql
• Vba
• Clinical Trials
• Advance Excel
• Pharmacovigilance
• Cdisc