Harivardhan Jampala

WORK HISTORY

EDUCATION

ABOUT HARIVARDHAN JAMPALA

Statistical Programming leader and extensive experience in Statistical Programming, in the pharmaceutical and Life Sciences industry, CRO- Regulatory submissions, Submission‑Ready Clinical Data Packages and Regulatory Compliance Deliverables- Biostatistical Programming, Expert in SAS Clinical Analytics- Innovation and build standards for the department- Project and Team management with End‑to‑End Delivery Management- Exploratory and Inferential Clinical Analytics, Regulatory Clinical Data Analysis and End‑to‑End Clinical Data Analytics with Process Automations- Managing remote teams and provide cross functional process improvements. Technical and People Leadership- SME in CDISC activities, Regulatory Data Standards Expertise and End‑to‑End CDISC Implementation- Program committee and Session chair in CDISC US interchange events- Session Charing in PHUSE US connect and SDE\'s- Translational Science & InnovationGood working knowledge of different phases of clinical trials. Skilled in SAS(SAS/BASE, SAS/MACROS, SAS/STATS, SAS/SQL, SAS/GTL),| R,| Power BI | PythonResponsible for programming activities in support of biostatistics and data management departments, Provide daily supervision of statistical programming personnel and operations to ensure achievement of departmental goals and levels. Independently handle routine personnel-related issues. Provide lead statistical programming support in the project specific programming of statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with company and/or sponsor Standard Operating Procedures (SOPs) or study specific guidelines. Manage and/or mentor statistical programming staff.Experience in lead and support programming roles for phase I-IV trials in oncology and across multiple therapeutic areas. Programming experience includes both CDISC (SDTM and ADaM) and non-CDISC programming like generating and validating TFLs and Supporting CDM team in their data checks with different DM tasks.