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Srinidi Vodeti

Statistical Programmer | SDTM | ADaM | TLFs | SAS SQL | SAS Macro | Oracle Clinical | CDISC Standards

Bengaluru

2+ years of work experience

N.V.DATA SYSTEMS PRIVATE LIMITED
Feb 20242 yrs 6 mosPresent

Bengaluru

Statistical Programmer with 2.5 years of experience in the clinical research and pharmaceutical industry, specializing in SDTM and ADaM dataset development, TLF generation, validation, and regulatory submission support. Experienced in Phase II clinical trials and proficient in Base SAS, SAS Macro, SAS SQL, SAS ODS, and Oracle Clinical. Strong knowledge of CDISC standards (SDTM & ADaM), FDA regulations, ICH-GCP guidelines, MedDRA coding, and clinical trial processes. Skilled in developing analysis-ready datasets, performing quality control validation, data cleaning, and generating Tables, Listings, and Figures (TLFs) according to Statistical Analysis Plans (SAPs). Hands-on experience with SDTM domains such as DM, AE, CM, EX, MH, VS, LB, DS, and ECG, as well as ADaM datasets including ADSL, ADAE, ADLB, and ADVS. Proficient in SAS procedures including PROC SQL, PROC REPORT, PROC FREQ, PROC MEANS, PROC TABULATE, and PROC FORMAT. Passionate about delivering high-quality clinical data solutions and collaborating with cross-functional teams including Biostatistics, Data Management, and Clinical Operations to support successful clinical trial outcomes and regulatory submissions. Core Skills: Clinical SAS Programming | SDTM | ADaM | CDISC | TLFs | SAS Macro | SAS SQL | Oracle Clinical | Pinnacle 21 | Data Validation | FDA Regulations | ICH-GCP | MedDRA | Clinical Trials

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Headline

Statistical Programmer | SDTM | ADaM | TLFs | SAS SQL | SAS Macro | Oracle Clinical | CDISC Standards

Location

Bengaluru

Work experience

Statistical Programmer at N.V.DATA SYSTEMS PRIVATE LIMITED, Feb 2024 - Present · 2 yrs 6 mos, Bengaluru, Statistical Programmer with 2.5 years of experience in the clinical research and pharmaceutical industry, specializing in SDTM and ADaM dataset development, TLF generation, validation, and regulatory submission support. Experienced in Phase II clinical trials and proficient in Base SAS, SAS Macro, SAS SQL, SAS ODS, and Oracle Clinical. Strong knowledge of CDISC standards (SDTM & ADaM), FDA regulations, ICH-GCP guidelines, MedDRA coding, and clinical trial processes. Skilled in developing analysis-ready datasets, performing quality control validation, data cleaning, and generating Tables, Listings, and Figures (TLFs) according to Statistical Analysis Plans (SAPs). Hands-on experience with SDTM domains such as DM, AE, CM, EX, MH, VS, LB, DS, and ECG, as well as ADaM datasets including ADSL, ADAE, ADLB, and ADVS. Proficient in SAS procedures including PROC SQL, PROC REPORT, PROC FREQ, PROC MEANS, PROC TABULATE, and PROC FORMAT. Passionate about delivering high-quality clinical data solutions and collaborating with cross-functional teams including Biostatistics, Data Management, and Clinical Operations to support successful clinical trial outcomes and regulatory submissions. Core Skills: Clinical SAS Programming | SDTM | ADaM | CDISC | TLFs | SAS Macro | SAS SQL | Oracle Clinical | Pinnacle 21 | Data Validation | FDA Regulations | ICH-GCP | MedDRA | Clinical Trials

Srinidi Vodeti - Statistical Programmer in Bengaluru | Tal