Likith GK

• Utilized Open source packages like Pandas, Numpy, Scipy, Math, Pandasql, Python, Regular Expression and other libraries for data transformation into CDISC compliant datasets.
• Involved in Agile methodology for Standards functionality development and GitHub for code version management.
• Recently developed Client level standard programs for Standard result calculation, Treatment unbinding programming, Range Indicator, Treatment emergent flag, Baseline flag, Reference dates, Last Participation dates, Death flags with test code and Visits from a lookup file in Python Language.
• Created ADSL, ADAE, ADCM, ADEG, ADVS, ADPR, ADQS, ADTTE and other ADAM Safety datasets in compliance to ADAM IG rules and created Study level Summary tables and listing for AE, DS, CM and MH domains
• Contributed to Cross teams trainings, to train Python programmers with clinical domain knowledge and SAS programmers with python programming skills. Also constantly involved in trainings for freshers on basic domain knowledge, New joiners for team on-boarding and Non programming team members for Programming business use case, Process automation and Functionality enhancement.
• Created Performance Qualification and Performance execution script for different functionality of product for adherence to 21 CFR part 11 regulation for software authenticity and reliability.
• Supported in delivering Proof of Concepts for product to multiple leading Pharma-companies.
• Participated actively in talent recruitment for programming teams and conducted programming interviews.
• Efficiently programmed Custom Functions in Python for study specific logic using Pandas framework , to increase software stability across clinical studies.
• Tactically developed OTB functions to scale up logic for numerous scenarios faced in general clinical trails using Python.
• Created Machine readable source document (Ground Truth) for machine learning model , Based on CDISC guideline to generate datasets for interminable clinical studies classified for general observational classes.
• Worked on Automatic mapping to target variable from raw dataset, with Intuitive approach of Metadata pre-processing .
• Contributed to Fine tuning of Machine Learning Model , to achieve prediction accuracy score of 90% in safety and 85% in efficacy domains.

• Monitored as role of Programming Lead for 7 trials for Massachusetts based client with responsibility of posting regular transfers. Successfully performed Roles and Responsibilities of Lead of Study Documentation, Resource Management, Project Scope and finance, Risk management and Quality Management.
• Created, delivered and maintained Data Transfer Program for converting raw data into SDTM domains. For Multiple Clients with activity based SDTM deliverable (Partnership Clients) and end-to-end deliverable (Full-service providers).
• Have hands on experience on all SDTM observational classes Interventions, Events, Findings, Findings About including Special Purpose domain and Trail Design domains
• Constructed Logic for all variables for ADSL, BDS, OCCDS and ADTTE according to ADAM Implementation guide and Completed In house ADAM trainings.
• Programmed Tables and Listings using Procedures TRANSPOSE, SORT, FORMAT, MEANS, REPORT, FREQ, SQL, NPAR1WAY, IMPORT, EXPORT with SAS ODS Options.
• Clear Comprehension of Scope of Work and flagging Out of Scope work . To accommodate impact on budgeted hours.
• Contributed to building Standard SDTM Library which was used as reference in partnership level.
• Presented Multiple topics to team on:

1. Overall Process of Data transfer programming (DTP).

2. SASPT tool for code sharing within similar trails.

3. Macros used for different functions in DTP process

4. Generating Medical review listings for multiple stakeholder.

5. Operation vendor file programming to convert unstructured vendor data into SDTM domain.

for new trainees and peer group for higher operational efficiency .

• Projected Estimated Average Coding (EAC) Hours for trails and divide projected EAC to different operating regions within organization based on company-client billing policies .
• Effectively Communicated timelines for programmers, data management team and Bio-statistics team. Flagged potential project risks to higher management.
• Developed Process automation for Log Automation to detect errors, Quality Improvement checks, Medical Review Listing to directly fetch input for particular listing from DVS and contributed to develop standard Macros like %BLFL, %MetaInfoOut etc

• Worked on Pinnacle21 Enterprise version and Community version. to validate datasets.
• Created Metadata 3.2 for Belgium based client trails according FDA guidelines.
• Developed Mapping Specification for SDTM and delivered it to client along with First Draft transfer.
• Generated Define XML version 2.0 and QC output with reference to Code-list and Metadata contents
• Created Annotation for CRF based on study specific requirement and from Standard Annotations.
• Communicated Data Issues to DM team for each transfer to improve overall quality of SDTM data and reconcile data.
• Developed CSDRG from pinnacle 21 tool to elaborate on unresolved data issues present in Final SDTM transfer.
• Contributed to creating new and updating existing Quality Checks to achieve High Quality deliverable for SDTM domain, Metadata and annotation
• Vendor File programming to tailor it to SDTM requirements for mentioned findings domain EG, LB, MB, PC, QS and RP .

• Communicated effectively with multiple internal stakeholders and Client for generate Medical Review Listings with ODS color coding
• Skillfully developed constructing logic for Trial specific Back-end checks including phase 3 for PC, LB , FA, IS and SV domains and Inclusion/Exclusion Criteria checks according to protocol

• Completed extensive training on all modules under pharmacy domain including SDTM, ADAMs, TLFs, Annotation, Metadata, Rave, Define, Pinnacle21, SAS and e-Submission package.