Girish Kankipati

•Write, test and validate SAS programs to produce analysis datasets, TLGs and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications. • Lead Phase I and co-lead Phase II for Oncology (Relapsed/refractory diffuse large B-cell lymphoma, Multiple Myeloma) • Generated various tables, listings for best clinical response, Progression Free Survival, Overall Survival, Complete Remission, Complete remission rate and Objective Response rate. • Highly efficient in mapping CDISC Tumor domains TU, TR and RS as per 3.2 SDTM IG. for various response Criteria such as Cheson 2007, Lugano 2014 and IMWG (International Myeloma Working Group). • Provided SAS programming support to Statisticians, Data Managers, and the Medical Writers to develop reports. •Write CDISC standard dataset specifications and follow specifications to create SDTM and ADaM datasets. •Generated Efficacy and Safety tables (Adverse Events, Patient Profiles, Demographics, Vital Signs, Laboratory Findings, and Study Completion). •Attended study management team meetings to represent programming and address issues related to deliverables and timelines. •Executed departmental, product and study-level macros and utilities. Write, test and validate product and study-level macros and utilities. •Communicated with Statisticians about various analysis dataset and TLG specification related issues. •Validated analysis datasets, tables, listings and ad-hoc queries generated by other statistical programmers.

• Developed efficacy and safety tables including AE tables, laboratory shift tables and Concomitant tables. • Generated various ADAM data sets, Efficacy and Safety Listings, Tables and graphs by using TFL Tool macros in SDD environment. • Involved in the QC and production of Tables/Listings for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA Submission. • Command over complete new drug & device release process from IND (pre-clinical) submission to FDA approval. This includes Clinical Trials (Phases I-III), preparation of IND, NDA, safety reviews, adverse event report reviews, risk factor, integrated safety and efficacy summary (ISS & ISE). • Used Stat procedures such as TTEST and MIXED to prepare various statistical results in RTF formats • Extensively used macros for generating shift tables, CT.gov tables and for creating Meta data for Analysis data sets. • Wrote programs in SAS to generate reports, creating RTF, HTML listings tables and reports using SAS/ODS for adhoc report generation

• Analyzed the design and development of Clinical Trial Projects, their implementation and testing in Pharmaceutical and Healthcare Industries. • Profound grasp over data cleaning and validation; manipulation and analysis report generation in compliance to requirements, implementing integrated application software of SAS. • Clear Comprehension of Clinical Trial protocol and CRF’s and revision of annotated CRF’s. • Command over complete new drug & device release process from IND (pre-clinical) submission to FDA approval. This includes Clinical Trials (Phases I-III), preparation of IND, NDA, safety reviews, adverse event report reviews, risk factor, integrated safety and efficacy summary (ISS & ISE). • Constructed data models like SDTM, ADaM, and ODM with CDISC, CDASH, MedDRA, and WHODRUG standards. • Created test scenarios to find errors and established programs meeting specifications. • Exposed to reviewing of code and program documentation. • Responsible for maintaining, storing, mapping and analyzing medical, lab and any other health data in compliance with HIPAA policies and procedures