Kiran H

Principal Statistical Programmer @Cytel

Bengaluru, KA, IN
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Nov 2024 — Present

Principal Statistical Programmer @Cytel

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Bengaluru, IN

EDUCATION

2008 — 2012

SAPTHAGIRI COLLEGE OF ENGINEERING

Bachelor of Engineering (B.E.), Biotechnology

2006 — 2008

S. Nijalingappa pu collge

Pre-university(PU), Science

1999 — 2006

Apollo High School

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

SKILLS

Microsoft ExcelR Graphical InterfaceSas/SqlClinical ResearchData ManagementCROFermentationProtocolEdc21 Cfr Part 11Excel DashboardsR StudioSasCRO ManagementSas/MacrosSopBiostatisticsValidationCdisc StandardsVisual Basic for Applications (Vba)Clinical DevelopmentUpstream ProcessingClinical Study DesignSdtmPharmacokineticsGood Clinical Practice (Gcp)Visual BasicIch-GcpSas ProgrammingBiotechnologyGcpBiopharmaceuticalsPl/SqlVbaClinical TrialsAdvance ExcelPharmacovigilanceCdisc

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.

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