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About Candidate
Technical Project Experience
Embarking on my role as a Junior clinical programmer, I utilized Base SAS programming as a
catalyst, transforming code into impactful narratives. Each debugging challenge was a strategic
victory, contributing to seamless coding and heightened efficiency. Advanced SAS case studies served
as my testing ground, translating theoretical expertise into practical solutions for real-world data
complexities. My unwavering commitment to precision in adhering to CDISC standards and SDTM
structures yielded reliable data, forming the bedrock for revolutionary research outcomes.
Leveraging Power BI, I converted raw data into compelling visuals, not just elucidating intricate
findings but also driving decision-making processes. This transformative journey has shaped me into
a results-focused data analyst, impacting the clinical research landscape. Armed with a formidable
skill set, I remain a driving force in advancing progress within the dynamic realm of healthcare data
analytics.
- Imported raw datasets and curated a new dataset following specifications, protocols and SAP (Statistical Analysis Plan).
- Utilized Proc SQL and sorted raw datasets and implemented conditional statements and macros for data manipulation.
- Applied various CDISC standards, including SDTM and ADaM, referencing different domains such as DM (Demographics) and AE (Adverse
Events).
- Employed Power BI tools for effective data visualization in support of analytical insights and reporting.
- Demonstrated expertise in data management and analysis through the comprehensive use of statistical procedures, data standards, and
visualization tools.
- Converted data from one format to another, such as from Excel data records to SAS datasets
- Analyzed data from clinical trials & Developed reports, listings and graphics to summarize data about interdependencies of data
points and the efficacy of trial-phase clinical therapies.
- Provided support to researchers and analysts.
- Developed and tested SAS programming codes for clinical trial database logical checks and data reports.
- Ensured adherence to clinical database standards, SOPs and Process Guidelines.
Education
During my B.Pharmacy studies at ICP, I honed proficiency in clinical and preclinical research methodologies. The curriculum provided an in-depth exploration of bioavailability, pharmacokinetics, and pharmacodynamics, laying a robust foundation for pharmaceutical understanding. Specialized coursework enhanced my expertise in precision drug formulation, ensuring dose uniformity and heightened therapeutic efficacy. My academic journey reflects a consistent commitment to achieving optimal dose precision, exemplified by a proven track record in pharmaceutical studies. Beyond coursework, my time at College granted me invaluable insights into the drug development process, fostering a holistic understanding of the pharmaceutical industry. I cultivated a dedication to elevating the user experience through precise and uniform dosing, aligning seamlessly with industry expectations. I am eager to leverage this comprehensive education and passion for pharmaceutical excellence as Clinical trail Data Analyst. Successfully graduated with CGPA of 8.21 , demonstrating solid academic performance and commitment to learning.
Completed higher secondary education with Percentage : 70.60 % , showcasing a commitment to learning and achieving well-rounded development in both academic and extracurricular pursuits.
Completed Secondary education with excellent grades and Percentage : 84.45 %, showcasing strong dedication and academic achievement.
Work & Experience
Reviewed and marked up clinical trial forms to guarantee accurate and complete data. This meticulous approach ensured smooth integration into the study database, ultimately enhancing the reliability of collected data for strong clinical research results Tech Stack : Blank CRF Excel Sheet, SAP, Clinical Study Protocol
In the SDTM domain dataset development project, I spearheaded the creation of the DM dataset, meticulously structuring and organizing clinical trial data to comply with CDISC standards. My efforts ensured a standardized and comprehensive representation of demographic information, contributing to the overall integrity of the study's data framework. Tech Stack : Base SAS, SDTM IG
Led the generation of the Laboratory Analysis Dataset (ADLB) by seamlessly integrating raw lab data (LB.sas7bdat) and subject-level analysis data (ADSL.sas7bdat). Applied expertise in structuring and mapping laboratory tests from the provided list (labtests.xls) and parameters information (adlb_paramcd.csv), showcasing proficiency in data transformation and dataset creation. Tech Stack : Base SAS, Proc Sql.
Led the validation and enhancement of ADaM dataset by seamlessly integrating raw lab data, conducting sorting and merging operations, and implementing comprehensive parameter coding. Executed meticulous calculations, including baseline variables, change (CHG), percent change (PCHG), and criteria variables, resulting in a refined dataset. Implemented last flag (ANLASTFL), maximum flag (ANLMAXFL), and minimum flag (ANLMINFL) for precise data categorization. Achieved project goals by ensuring dataset compliance with specifications and generating the final labeled output dataset, contributing to data integrity and analysis accuracy. Tech Stack : Base SAS, Pro Sql
Led SAS Data Integration project for PK analysis, seamlessly merging PK concentration data from diverse sources (bapk.xls, dmg.xpt, vsn.xpt, dar.xpt, bcl.xpt) into the clinical database. Expertly utilized PROC procedures to import, sort, merge datasets, applying conditional statements for data refinement, and delivering the final dataset in XPT format, optimizing accessibility and analysis efficiency.
Generated detailed SAS reports by crafting code for two custom summary sheets, utilizing sorting, merging, PROC TEMPLATE, and PROC REPORT to organize demographic and adverse event data from analysis datasets (demo.sas7bdat, adverse_event.sas7bdat), resulting in insightful reports in Demo.rtf and Adverse_Event_Report.rtf formats.
Led a project involving the utilization of input datasets adsl.sas7bdat and admh.sas7bda to generate two final reports, T14.1.1.rtf and T14.4.1.rtf. Established a logical flow by cross-referencing developer RTF reports for formatting, writing independent SAS code to validate datasets against requirements, comparing final datasets with developer reports, and storing comparison results for comprehensive analysis.
'Summary of Physical examination (Safety Analysis Set)' report was independently generated using SAS, showcasing competence in data analysis, project management, and regulatory compliance.
‘Summary of Medical/Surgical History (Enrolled Population set)' report was generated using SAS, following formatting guidelines, analyzing data, combining datasets, and computing statistics.
Generate the ‘Summary of Dose limiting toxicities (Safety Population)’ report by writing independent code in SAS.
Generate the ‘Analysis of Response Criteria for Tumor Assessment (PP Population)’ report by writing independent code in SAS.