Pavani Ravikindi

Clinical Programming Activities

• Provided SAS programming support for data management team to analyze clinical trial data and validation of tables, listings and reports.
• Developed Standard Data Management , Medical Monitor, Vendor Reconciliation and Sponsor specified Custom safety listings.
• Developed standard macros to generate Incremental Listings, Missing Pages Reports, Custom listings, CPT, SDV, Reconciliation reports for different datatypes like ECG, LAB, ePRO, Safety etc.
• Developed complex coding macros to generate Data Management Listings, enhancing reporting efficiency across multiple studies.
• Developed standard RECIST 1.1 macro which can be used across several Oncology studies.
• Developed reusable SAS macros to automate RECIST 1.1 Target/Non-Target/Overall response derivations.
• Designed parameter-driven SAS macros to calculate Sum of Diameters(SoD), finding Smallest sum (NADIR), percentage change from baseline/nadir as per RECIST 1.1 guidelines.
• Developed and validated SAS macros for handling complex RECIST Scenarios, including missing assessments, missing methods, New lesions(unequivocal), and non-target progression.
• Coordinated development activities for clinical programming projects, identifying and escalating issues impacting timelines and resources to project management while balancing multiple tasks.
• Provided Clinical SAS programming and analysis support for clinical studies across multiple protocols for submissions such as CSR and Safety.
• Conducted extensive quality checks on team members' tasks and facilitated data validation and cleaning throughout all phases of clinical studies.
• Worked on multiple protocols and/or drug compounds at a time.
• Extensively worked in Developing, Debugging, and validating project-specific SAS programs to generate derived SAS datasets, summary tables, and data listings according to departmental standards.
• SAS macros were successfully used to create new programs and modify existing SAS programs to make them portable as well as for consistency of results.
• Collaborated with the data management team to handle documentation and submission processes.
• Ensured analysis data and programming code meet regulatory and company standards (FDA and ICH regulations) and are consistently structured to permit efficient programming and reporting.
• Render support in generating analysis data sets and creating specified structured reports by creating Macros and macro variables using %LET, CALL SYMPUT, and DATA _NULL_
• Leads clinical programming activities on concurrent studies depending upon scope, similarity, program, and resourcing requirements

Statistical Programming Activities

• Utilizing knowledge of CDISC standards like SDTM to create and review Mapping Specifications.
• Included in development and validation of Annotated Case Report Forms (aCRFs)
• Developing and validating all the SDTM related datasets, running through Pinnacle 21 to resolve all the issues.
• Generating, preparing and maintaining all required documentation for submission deliverables such as define.xml, annotated CRFs and Reviewer guides.
• Performed rigorous validation, including double programming and independent review, to ensure accuracy and regulatory compliance

• Collaborated with Statisticians and Data Managers to deliver SAS programming for comprehensive analysis of Clinical Trial Data.
• Worked on writing, editing, validating and debugging code in BASE SAS and MACROS.
• Produced final study reports, tables, and listings utilizing PROC SQL, PROC TRANSPOSE, PROC REPORT, PROC FREQ, and DATA step to ensure accurate data presentation.
• Created analysis datasets from raw datasets and maintained large datasets by using Set, Merge, Sort, Keep, Drop, Update, Formats, Functions and conditional statements.
• Experienced in validation of Tables, Listings, Graphs and Analysis Datasets using Proc compare and departmental standard macros.
• Generated programs in MACROS to generate listings, quality tables for clinical study reports and regulatory submissions.
• Developed CRT (Case Report Tabulation) datasets adhering to CDISC standards for successful FDA regulatory submissions.