Clinical Research Trials

Uday Kumar

Senior Statistical Programmer

Email: *****.*******@*****.***

Ph: 984-***-****

Professional Summary

Senior SAS programmer with 10+ years of experience worked with Clinical research organizations (CRO) and Pharmaceuticals Company on Phase I-Phase III clinical trials.

Worked on various therapeutic areas such as oncology, vaccine studies, and cardiovascular diseases.

Involved in the CRF annotations, mapping raw data to standard SDTM domains as per the SDTM Implementation guide standards and specifications.

Good experience and knowledge in working with CDISC standards for generating SDTM and ADaM datasets and validating them as QC programmer.

Experienced in the creation of analysis datasets for Safety and Efficacy per the specifications provided based on the SAP.

Generated Table, listings, and Figures (TLF’s) accordingly, with provided Mock shells and SAP.

Ensured compliance by validation, performed data validations by Pinnacle 21 and documented Study Data Reviewers Guide (SDRG) and Analysis Data Reviewer’s Guide (ADRG).

Proficient in Macro Facility and debugging, SAS Procedures, and SAS functions, Merging SQL Joins.

Possess good problem-solving skills and have working experience of CDISC and industry related standards.

Good knowledge of Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE), involved in pooling data from different studies.

Experience in supporting FDA submission related activities like converting SDTM & ADaM datasets into .xpt files, generating define.xml, and creation of Ad-hoc reports.

Generated HTML, PDF and RTF reports using SAS Output Delivery System (ODS).

Supported data management team in reconciliation checks, patient profiles, DM listing output and medical listings.

Proficient in using standard SAS procedures like PROC SORT, PROC MEANS, PROC FREQ, PROC COMPARE, PROC TRANSPOSE, PROC IMPORT/EXPORT, PROC FORMAT, PROC REPORT.

Good knowledge of controlled terminology and medical dictionaries.

Exceptional problem-solving skills for delivering useful and prudent solution. Excellent written and communication skills, good team player and always open to learn.

Skills

SAS Skills:

SAS V9.4, Base SAS, SAS/GRAPH, SAS/Macros, SAS/STAT

SAS Procedures:

Report, Print, Freq, Means, summary, univariate, SQL, Sort, Transpose, Contents, Options, Import, Export, Format, sgplot, lifetest..etc.

Clinical Trials:

Phase I, Phase II, Phase III

Operating Systems:

Windows XP/2000, Windows 7, 8, UNIX

Data base Software:

Medidata Rave, Inform and Oracle Clinical

Applications:

SAS, MS Office, MS Word, MS Excel, MS power point, Pinnacle

EXPERIENCE

Veristat, Southborough, MA

(March 2015-Present)

Sr. SAS Programmer

Responsibilities:

Analyzed safety and efficacy data from Phase II and III clinical trials.

Involved and worked in coordination with Statisticians to develop the mapping specifications for the development of SDTM datasets.

Understood and utilized company utility macros and tools for clinical trial reporting.

Worked with various Versions of MedDRA, getting the adverse event codes and in grading laboratory toxicity grading, WHO drug for coding concomitant medications and medical history terms.

Assisted in validation, edit checks and data review listings.

Created ad-hoc reports as per the requirements.

Used CDISC knowledge to develop SDTM datasets for various domains and ADaM analysis datasets.

Analyzed the clinical trial data in collaboration with biostatisticians and clinical data managers and worked jointly to generate final study reports, tables, graphs and listings.

Used MACROS effectively to improve the process of coding and to standardize programs.

Formatted XML, RTF and PDF reports using SAS output delivery system (ODS).

Implemented LOCF (Last Observation Carried Forward), WOCF (Worst Observation Carried Forward) analysis for some longitudinal trials with missing data.

Worked on documentation for regulatory submission such as define.xml, define.pdf and assisted in reviewing CSR (clinical study report).

Successfully handled multi-projects at a time.

Involved in developing, testing and writing programs & reports in SAS according to required specifications.

Generated safety & efficacy tables, patient profile, demographic listing, vital signs and reason for withdrawal from the treatment for FDA submissions.

Developed new specifications and verified already written specifications for the Analysis datasets. Developed reports using PROC REPORT.

Involved in SAS programming with Clinical Trials data for Phase I-III in different studies.

Mapped Legacy data in SDTM format and created analysis datasets based on ADaM standards.

Generated tables and listings based on the List of Tables (LOT) and Mock tables.

Created study specific datasets to be used in production and QC processes such as demographic data (DM) tables, Adverse Events (AE) tables, Serious Adverse Events (SAE) tables, Laboratory data (LB) tables etc.

Developed Edit check programs for data validation before final analysis

Developed Macros to support programming of Analysis datasets, Tables and Listings.

Investigated missing data and data anomalies in SAS datasets.

Generated reports in different formats like RTF, PDF and HTML using SAS output delivery system (ODS).

Worked on production of SDTM and ADaM datasets. Reviewed CRF, SDTM specifications and ADaM specifications.

Performed validation of the datasets using PROC COMPARE and Pinnacle 21.

Worked on both production and validation of TLF’s according to SAP, mock shell and gave validation comments as a part of review process.

Verified accuracy and integrity of clinical data by performing validation checks and data cleaning by investigating data related errors and missing values.

Reviewed define.xml documentation and created reviewers guide for SDTM and ADaM datasets.

Work together with study level programmers to ensure smooth conduct of programming activities.

Interact with other departments to ensure a high level of client satisfaction through successful execution of projects.

Participated in project meetings, presentations and updating research findings.

Chiltern,Wilmington,NC

(April 2014- March 2015)

Clinical SAS Programmer

Responsibilities:

Performed statistical analysis using SAS/Base, SAS/Macro and other procedures like Proc freq, Proc Univariate and Proc Means.

Generated listings and reports from SAS programs using MACROS, ODS and PROC TEMPLATE/REPORT/TABULATE and using Word, Excel and PowerPoint as well.

Used Proc Import for importing data from Excel sheets, CSV files and other raw data files.

Communicate with the clients and resolve data issues quickly to progress the project.

Proficient in understanding of Study Protocols and CRF's.

Created Safety and Efficacy customized reports for FDA regulatory submissions.

Prepared SOPs and guidance documents to be used in SDTM conversion process.

Created new datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, and conditional statements.

Validated, documented and tested component programs in an efficient manner for inclusion in integrated reports.

Developed, analyzed and designed SAS programs in UNIX platform.

Generated highly customized reports in the form of listing, HTML, RTF and PDF using SASODS, PROC REPORT, PROC TABULATE, and PROC SQL.

Review supporting documentation produced by other SAS programmers. Receive, import, and verify structure of external data.

EDUCATION

Graduate: Boston University

Master’s in public health

Medical School: Dr. Ambedkar Medical College

Medical Doctor

Undergraduate: Dr. Ambedkar Medical College

Bachelor of Medicine and Surgery

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