Nagarjuna Reddy SEELAM

• Skilled in extracting data from external sources and developing ADaM datasets using SAS 9.4.
• Experienced in creating ADaM datasets, Tables, Listings, Figures (TLFs), reports, and summaries according to Statistical Analysis Plans (SAPs) and mock shells.
• Strong hands-on experience with Base SAS, SAS Macros, SAS/ODS, and SAS/SQL in Windows environments.
• Worked on ADaM domains such as ADSL, ADLB, ADVS, ADMH, and ADAE.
• Worked on SDTM domains including DM, LB, VS, MH, and AE.
• Ability to review SAPs and TLF shells from a programming perspective.
• Proficient in data manipulation using SAS formats/informats, merge techniques, PROC DATASETS, PROC SORT, PROC TRANSPOSE, PROC MEANS, and generating safety reports.
• Experienced in validating ADaM datasets and listings using PROC COMPARE.
• Strong command in generating reports using PROC REPORT, PROC MEANS, PROC FREQ, and PROC TRANSPOSE.
• Good knowledge of clinical trial phases (Phase I–III).

Project-1: SDTM Creation & Validation (CMP-135)

Title: Phase II, Double-Blind, Randomized, Placebo-Controlled Trial in Ovarian Cancer.

Responsibilities:

• Created SDTM domains DM, EX, MH, DS, and VS by mapping raw CRF datasets to SDTM standards according to SDTM IG and study specifications.
• Performed validation of SDTM datasets using PROC COMPARE, ensuring 100% match with primary programmer outputs.
• Reviewed SDTM specifications, aCRF, and protocol to ensure accurate variable derivations, controlled terminology, and domain compliance.
• Gained hands-on experience with SAS coding, Data Step, SAS Macros, PROC SORT, PROC TRANSPOSE, PROC REPORT, PROC SQL.
• Generated all deliverables including SAS code, log files, and validation reports (PDF/RTF), maintaining regulatory submission quality.

Project-2: ADaM Dataset Creation & TLF Generation
Title: Phase II, Double-Blind, Randomized, Placebo-Controlled Trial in Ovarian Cancer.

Responsibilities:

• Developed ADaM datasets ADSL, ADLB, ADVS, ADAE, and ADMH based on SDTM datasets and study specifications.
• Generated Tables, Listings, and Figures (TLFs) according to the Statistical Analysis Plan (SAP) and mock shells.
• Performed validation using PROC COMPARE to ensure dataset accuracy and 100% match with expected outputs.
• Strong hands-on experience with SAS Base, SAS Macros, SAS/SQL, PROC SORT, PROC TRANSPOSE, PROC REPORT, PROC MEANS, PROC FREQ for data manipulation and reporting.
• Reviewed SAPs and TLF shells from a programming perspective, ensuring compliance with CDISC standards and regulatory requirements.