Chandrashekhar Neela
Summary
Dedicated and Detail-Oriented SAS Clinical Programmer with 3+ years of experience in data analysis, niched within clinical research. Keenly looking forward to leverage my experience and skills in clinical statistical programming to contribute effectively to a dynamic healthcare organization focused on improving patient outcomes and advancing medical research.
Overview
3
3
years of professional experience
7
7
years of post-secondary education
Work History
Statistical Programmer - II
Clinztech Research Solutions Pvt. Ltd
03.2021 - Current
- Supported the creation of CDISC datasets (SDTM, ADaM) for regulatory submissions
- Developed and Maintained SAS programs to ensure data accuracy and consistency
- Collaborated with cross-functional teams including biostatisticians, data managers, and clinical operations to support data analysis needs
- Conducted QC checks on datasets and programmed outputs to ensure data integrity and consistency
- Assisted in the development and execution of SAS programs for data management and statistical analysis of Phase I-IV clinical trials
- Used SAS/ODS for generating different output formats like RTF, PDF, HTML and XLS as needed for the reports
- Developed and validated SAS programs for clinical trial data analysis, ensuring accuracy and adherence to regulatory guidelines (ICH-GCP, CDISC)
- Produced TLFs (Tables, Listings, and Figures) for clinical study reports (CSR) and submissions to regulatory authorities (FDA, EMA)
- Have Knowledge on SDRG and ADRG and Pinnacle 21 validation
- Worked on updates as required by statistics team and reviewers in time
- Excellent problem-solving and analytical skills, Strong attention to detail and ability to work under strict deadlines
- Effective communication and collaborative abilities.
Education
B.Tech-EEE -
Jawaharlal Nehru Technological University Hyderabad
Rangareddy, India 01.2016 - 04.2019
Diploma-EEE - undefined
State Board Of Technical Education And Training
Rangareddy, India 01.2013 - 04.2016
Projects
Cardiovascular System, Worked on Specification writings and Adam datasets generation like ADSL, ADQS, ADTTE(Non-CDISC standards)., Generated and validated safety Tables and Listings., Worked on figures using PROC LIFETEST and PROC SGPLOT., Worked along with CDM team on data issues., Addressed the sponser comments along with biostatisticians and worked on updates and requirements that are needed for the later submissions. Hepatitis C, Worked with safety data to generate and validate summary tables, listings and figures by adhering to the timelines using various procedures like PROC SQL, PROC FREQ, PROC MEANS, PROC SUMMARY, PROC TRANSPOSE, PROC SORT, PROC REPORT, PROC SGPLOT, PROC COMPARE., Used SAS functions (character, numeric and data and time)., Worked on CRF Annotation., Created and Validated SDTM Domains like DM, AE, CM, MH, DS, VS, IE etc., as per specifications on the basis of SDTM IG 3.2., ADAM domain mapping using specifications, codelist and CRF.
Languages
English
Hindi
Telugu
Profile
dbgtnb
Timeline
Statistical Programmer - II
Clinztech Research Solutions Pvt. Ltd
03.2021 - Current
B.Tech-EEE -
Jawaharlal Nehru Technological University Hyderabad
01.2016 - 04.2019
Diploma-EEE - undefined
State Board Of Technical Education And Training
01.2013 - 04.2016
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