Jins Thomas Email & Phone Number

• Statistical programming for Phase 3 and Phase 4 clinical trials in the cardiovascular therapeutic area of medical devices, overseeing data analysis and TLF creation, utilizing SAS programming language• Generation of SDTM and ADaM specifications in accordance with CDISC standards, mapping variables from CRFs to standard SDTM variables, and generating SDTM and ADaM domains from raw datasets. • Demonstrated expertise in creating various SDTM domains and intervention-specific domains using SAS, based on protocol and supplementary datasets. • Developing and Automating SAS programs to generate Tables, Listings, and Figures (TLFs) as per statistical analysis plans and clinical study protocols, ensuring alignment with the cardiovascular medical device trials. • Conducted thorough validation of TLFs, employing stringent data checks and cross-referencing with source data to uphold accuracy and consistency in statistical outcomes.• Experienced in leveraging SAS statistical methods such as Base and advanced SAS for advanced statistical analysis and visualization of clinical trial data, enabling comprehensive exploration of treatment efficacy, safety profiles, and patient outcomes.

• Led statistical programming efforts for Phase 2 and Phase 3 Oncology and CNS clinical trials,including involvement in the authoring of clinical trial reports (Phases I-III) and the analysis and submission of trial results to the FDA.• Good experience with creating SDTM - special purpose like DM, SV, SE. Intervention CM, EX, Events AE, DS, MH, Findings datasets of LB, VS, EG, PC, PP and TDM’s from protocol and other SUPP and RELREC datasets. • Responsible for creating Adam Datasets like ADSL, BDS datasets like ADVS, ADLB, ADTTE, ADEXSUM and other occurrence ADAE, ADCM datasets. • Performed rigorous validation checks on SDTM and ADaM datasets using Pinnacle 21 software to ensure data integrity, compliance with CDISC standards, and regulatory requirements.• Collaborate with cross-functional teams to identify and resolve data quality issues, providing in-depth analysis and actionable recommendations to improve dataset quality and accuracy.• Responsible for performing statistical analysis and creating summary tables, such as Adverse Event (AE) listings and tables, Demographics, and Patient Disposition tables, to summarize clinical trial results.• Generated graphical charts, including Bar charts, scatter plots, Kaplan-Meier survival curves, Forest plots, and Line listings, to effectively communicate clinical trial outcomes and safety profiles.• Develop and maintain SAS programs to generate Tables, Listings, and Figures (TLFs) in accordance with statistical analysis plans and clinical study protocols.• Perform thorough validation of TLFs by conducting data checks, cross-referencing outputs with source data, and ensuring the accuracy and consistency of statistical results.• Proficiency in preparing and managing clinical trial submission package documents, including annotated CRF, define.xml, eSDRG (Electronic Study Data Reviewer's Guide), and eADRG.

Master'S Degree, Mathematics

Bachelor'S Degree, Education

Bachelor'S Degree, Mathematics