Dharma dev Bommi

Complete programming responsibility of clincal trial with team of 9 people. Writing ADaM Specifications/ Development/Validation of ADaM datasets. Generate and analyze PINNACLE21 checks to ensure ADAM datasets comply with CDISC standards. Define metadata and generating define.xml v2. Programming with python for data analysis to get insights of Real-world evidence data by making use of statistical methodologies, model building and selection.

Developed macros for tables and components in ADaM datasets. Collaborated with CDM, Medical Writing (MW) throughout trial, with MW and Regulatory for answering FDA/EMEA questions with strict deadlines, with Market Access to support Health Technology Assessment, pricing. Worked together with Safety department to generate PSUR, DSUR reports and for other exploratory activities. Collaborated effectively as trial programmer with multiple CRO’s from different countries.

Responsible for generating tables, listings & datasets for Neurologic disorder, Rheumatoid arthritis, Hepatitis c Virus trials. Perform self QC for generated reports and datasets. Perform Validations of listings & tables. Identify potential data errors in database and report. Work on PK, PD, Bio-marker data to produce Pharmacodynamics

Pharmacology

Clinical Pharmacy, Pharmacology, Pharmaceutics, Meidicinal Chemistry, Pharmaceutical Engineering, Statistics, Computer Science.