Nagarathnam A
Principal Statistical Programmer @Cytel
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WORK HISTORY
Principal Statistical Programmer @Cytel
TX, US
Professional SAS programmer with 10 plus years of experience in Statistical Programming in Clinical Trials. • Extensive experience in leading Phase-3 Oncology studies.• Well experienced in SAS and R programming.• Worked on End-to-End from CRF annotation to submission.• Worked on phase I, Phase II and Phase of clinical on various study designs.• Good understanding of Study Protocols, SAP (Statistical analysis plan) and CRF’s.• Good knowledge of GCP, GPP and US FDA & CFR Part 11 guidelines related to generating the Clinical Reports and Electronic records as well. • Generated various safety and efficacy TLF and their reports using PROC REPORT, PROC MEANS, PROC FREQ, PROC TRANSPOSE, PROC LIFETEST, PROC PHREG and PROC MIXED as per mock shells using analysis datasets.• Familiar in writing Macros to create SAS datasets, TLF, as well as convert various file types to SAS Datasets.• Good knowledge over CDISC SDTM-IG models and ADaM-IG (v1.1)• Extensive experience in creating TLF mock shell documents.• Extensive experience as Oversight lead and Out-Licensing lead.• Extensive experience in working on publication work, DSUR, IA, Tumor Response Listings, Patient profiles, exploratory analysis and Adhoc request from FDA.• Extensive experience in leading Pinnacle 21, CRT package, define.XML, Reviewers’ guides activities.
EDUCATION
Sri Venkateswar College of Engineering &Technology, RVS Murukambattu, Chittoor, JNTU Ananthapur.
Bachelor's degree, Information Technology
ABOUT NAGARATHNAM A
With over a decade of experience in Clinical SAS programming, currently contributing as a Principal Statistical Programmer at Cytel, focusing on transforming complex oncology data into actionable insights. Proficient in creating ADaM datasets, TLFs, and Data Definition Tables (DDT) adhering to CDISC standards, enabling efficient regulatory submissions. Expertise in oncology endpoints, including progression-free survival, overall survival, and response duration using RECIST V1.1 and mRECIST guidelines. Skilled in leveraging statistical analysis plans and programming plans to produce high-quality outputs such as tables, listings, and graphs. Partnering with cross-functional teams to ensure seamless execution of clinical trials. Committed to driving data accuracy, compliance, and innovation in clinical research while mentoring and guiding teams to achieve organizational goals.
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