Clinical Data Analysis

Name: DEEPTI MATTA

E-mail: ***********@*****.***

Phone number: 470-***-****

Summary

SAS Certified Programmer with over 9 years of SAS programming experience in Pharmaceutical and CRO industries.

Extensive knowledge in Clinical Data Analysis (Phase I – IV).

Advanced programming skills in SAS/BASE, SAS/ACCESS, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/SQL, and SAS/MACROS.

Excellent knowledge in Clinical trial study designs and clinical operations.

Knowledge of various clinical documents such as Protocol, CRF, ACRF, and SAP

Experience in annotating CRF, reviewing CRF, and Reviewing SAP.

Extensive experience in CDISC SDTM as well as ADaM standards.

Involved in creating and validating Tables, Listings and Graphs from the analysis datasets.

Hands on experience in integration studies such as ISS and ISE.

Used Open CDISC validator to verify the CDISC compliance of transport (.xpt) files.

Proficient in handling multiple projects.

Working knowledge in MedDra and WHO dictionaries.

Supported define.xml activities.

Converted events of interest sheets to SAS datasets in windows as well as UNIX environment.

Adept handling of SDTM and ADaM datasets in accordance to CDISC standards.

Experience in debugging and testing SAS programs to check and process data.

Experience in creating new macros and also updating client specific macros as per requirements.

Individually capable of developing new SAS Programs and/or enhancing existing SAS programs from protocols and SAP’s.

Worked in global as well as local teams.

Used proc means, freq, transpose, report, format, sort and print on a day-to-day basis.

Experience in creating various output formats such as rtf, pdf, and html using SAS ODS.

Created and maintained SAS macros and utilities.

Excellent verbal, written communication and analytical skills.

Possess a strong ability to adapt and learn new technologies and new business lines rapidly.

Successfully handled responsibilities for extracting internal/external data, data cleaning, and validation, analysis, and report generation.

Good analytical skills pertaining to understanding of the business domain coupled with excellent team work and communication skills

Technical Skills

Statistical analysis using SAS® (SAS SQL, Macros, Procedures)

SAS Procedures: Print, Means, Tabulate, Univariate, SQL, Report, Freq, Sort, Summary, Format, Import, Export, Transpose, Compare, Gplot and Gchart

Operating system: Unix, windows

Database software: Oracle, clintrial, SQL

Office tools: Microsoft word, Excel

Open CDISC validator tool

Education

B. Tech (Chemical Engineering) from JNTU.

Ephicacy Life Sciences, New Jersey, USA

JUN 22 – Current

Sr. Programmer Analyst

Worked on Phase I, II and III clinical data.

Used the Import and Export facilities in SAS to exchange data between SAS and Microsoft Office environments (Excel, Access).

Written mapping document and specifications for individual studies.

Written specifications for various projects including ISS studies.

Involved in FDA submissions.

Worked extensively on Programming and validating Analysis datasets in adherence to CDISC ADaM standards.

Responsible for developing reports for Safety and efficacy as per study requirements.

Worked extensively to generate complex outputs using Proc REPORT.

Worked on survival analysis and creating KM plots using PROC LIFETEST.

Worked on several ad hoc outputs as per client requirement.

Extensively used Proc SQL to retrieve, update and report on information from SAS data sets.

Worked on integration studies such as ISS and ISE.

Good knowledge on handling missing or partial dates.

Developed macros for reports and created utility macros.

Performed Quality Check extensively on tasks performed by other team members and involved in data validation and data cleaning.

Modification of existing SAS programs and creation of new programs using SAS Macros.

Involved in validating and updating specific macros based on the need.

Worked on multiple protocols and/or drug compounds at a time.

Parexel Pvt Ltd

Jan 19 – May 22

SAS Programmer Consultant

Handled multiple requests by prioritizing tasks according to timeline and dependency.

Responsible for complete delivery of project.

Worked extensively in CDISC SDTM and ADaM.

Assigned tasks to various programmers and monitored the progress.

Developed Analysis dataset specifications based on SAP and TLG shells.

Negotiated timelines with statistician.

Prepared specifications for pooling of datasets with different data structures based on TLG shells, CRF and study level specifications.

Annotated TLG shells for programming.

Used different statistical procedures like PROC PHREG, LOGISTICS, ANOVA to create tables and graphs as per statistician’s request.

Created and validated analysis data sets and SAS-generated outputs (tables, listings and graphs) via independent programming.

Upgraded MedDra versions of older studies to the latest version to facilitate pool analysis.

Maintained and updated existing utilities as per project requirements.

Provided technical leadership, supervision and technical solutions to programming issues within the product team.

Ensured best programming practice through leadership of programming process improvement initiatives.

Active involvement in knowledge sharing via presentations at monthly programming meetings.

Cognizant

Jan 17 – Dec 18

SAS Programmer

Performed edit checks on the legacy data before the legacy data is converted into Standard data.

Created datasets in CDISC SDTM V 3.1.2 format according to CDISC SDTM Implementation guide

Worked on analysis data sets (ADAM) to reflect the specifications, ADAM implementation guide and the Statistical Analysis Plan (SAP).

Used various Procedure steps like PROC FREQ, PROC SORT, PROC MEANS, PROC TRANSPOSE and PROC SQL to perform Statistical analysis and to generate the reports.

Used SAS/Macros extensively in analysis of standard clinical data and generated REPORTS, GRAPHS, LISTINGS, and TABLES

Created project specific MACROS, TEMPLATE and FORMAT catalogue.

Involved in creating project specific datasets and tables for interim analysis.

Developed TABLES, LISTINGS and GRAPHS for various studies as per the Statistical Analysis Plan (SAP).

Used PROC REPORT and SAS/ODS feature to create the TABLES and LISTINGS

Involved with the Validation of SDTM datasets, ADAM datasets, TABLES and LISTINGS

Extensive experience in creating LABORATORY tables (Summary, Shift of Lab values, Shift Categorization).

Created standard macros and applications to improve the efficiency of the department.

Involved in various projects and was an active team member in project meetings interacting with Biostatisticians, Team leaders and project managers to analyze the data and to discuss the status of the project.

inVentiv Health

Jan 15 – Dec 16

SAS Programmer

Handling large datasets, ensuring data quality, and preparing data for analysis.

Performing statistical tests and creating models to derive meaningful insights.

Producing tables, listings, and graphs (TLGs) to summarize data findings.

Writing SAS programs to extract, clean, and prepare data from various sources.

Transforming raw data into structured formats suitable for analysis.

Validating datasets and ensuring they meet predefined specifications (e.g., CDISC standards like SDTM and ADaM in clinical research).

Implementing statistical methods using SAS procedures such as PROC MEANS, PROC FREQ, PROC UNIVARIATE, PROC REG, etc.

Generating detailed statistical summaries, trend analyses, and visualizations.

Preparing customized reports for stakeholders.

Reviewing and validating code written by other programmers.

Performing data checks to ensure accuracy and consistency.

Documenting programming processes for audit purposes.

Creating submission-ready datasets for regulatory authorities.

Generating study protocols, statistical analysis plans (SAPs), and clinical study reports (CSRs).

Ensuring compliance with relevant guidelines, such as GCP (Good Clinical Practice) and 21 CFR Part 11.

Developing macros and reusable code for repetitive tasks.

Optimizing SAS programs to improve performance and reduce execution time.

Troubleshooting data inconsistencies or software issues.

Debugging and resolving errors in SAS programs.

Contact this candidate