Ramyaa N

Performed various programming tasks in Phase II/III clinical trials in Oncology TA.

• Developed and validated CDISC ADaM IG 1.0 compliant data sets from SDTM and raw datasets based on requirements specified in the metadata.
• Involved in development and validation of safety datasets like Subject level information (ADSL), Adverse Events (ADAE), Labs (ADLB), Vital Signs (ADVS) and efficacy datasets like Time-to-event (ADTTE).
• Created and validated Tables, Listings and Figures according to the Statistical Analysis Plan (SAP) and mock shells.
• Integrated data from multiple studies for ISS and ISE.
• Worked on New Drug Application (NDA) submissions to FDA, EMEA and other activities including Investigator Brochure (IB), preparation for ODAC, Poster presentations, IND Annual Reports, Drug Safety Update (DSUR) and Periodic Safety Update (PSUR).
• Extensively used procedures like PROC REPORT, PROC MEANS, PROC FREQ, PROC SQL, PROC GPLOT, PROC MIXED, PROC GLM to generate TLFs for various safety and Efficacy analysis
• Imported and exported data from non-standard sources like excel spreadsheets (.xls), Comma Separated files (.csv) and transport files (.xpt).
• Worked with Biostatisticians, Data Managers, Lead programmers and peers as a team to understand requirements and resolve any analytical or data issues
• Effectively collaborated with offshore teams by creating clear and precise communication, scheduled meetings and proper tracking documentation.

Performed various SAS programming tasks in a support role.

• Created Analysis Datasets, Table Listings and Figures as per mock-up and specifications provided by Lead programmer.
• Involved in development and validation of TLFs for Adverse Events, Clinical Laboratory Evaluations, Concomitant Medications, Subject Disposition, Tumor assessments and Prior Chemotherapy.
• Developed efficient, well documented and modifiable SAS code using BASE SAS and SAS Macro facility.
• Applied SAS procedures like PROC REPORT, PROC MEANS extensively for report generation in individual studies.
• Responsible for the proper coding, documentation and validation of SAS programs and macros for all analysis.
• Interacted with Statisticians for gathering requirements and assisted in developing listing and table specifications.