Ranga Babu Maddineni

Statistical Analyst @AbbVie

Responsibilities: • Understanding the description of the clinical study design, Primary and secondary objective(s) of the study, Primary and key secondary endpoints, Definitions of the analysis populations, Methods of handling the missing data, and Description of interim analysis, including DMC, IB, and DSUR activities. • Developed Analysis datasets (ADaM) specifications. • Produced and validated the Analysis datasets for both Safety and Efficacy analysis. • Produced and validated Tables, Listings and Graphs (TLGs) for CSR Analysis and extensively worked on all 14.1(Baseline),14.2(Efficacy), and 14.3(Safety) tables. • Validated the Analysis datasets in Pinnacle 21 and makes sure the datasets are compliance with CDISC standards. • Produced the define.xml and prepared the Analysis Data Reviewers Guide (ADRG) for Regulatory submissions. • Produced and validated the Clinsite dataset for OSI/BIMO submission package. • Worked on various imputation methods (Non-responder Imputation –NRI, Multiple Imputation –MI, and Last Observation Carried Forward –LOCF) to impute missing values per study specific SAP. • Extensively involved in Data cleaning, Verification, Validation Procedures and documentation of Clinical Trial data. • Worked with Statisticians and Clinicians to come up with design specifications for non-standard tables and listings required for a study.