Clinical SAS programmer

Ami Patel

*************@*****.*** +1-732-***-**** New jersey, USA

Professional Summary

Over 10 years of experience in the healthcare domain, specializing in SAS (Base SAS, Advanced SAS, and SAS Macros) on Windows, UNIX, and mainframes, as well as AWS migrations. Proficient in SAS 9.3 to SAS 9.4 AWS migration, involving the transition of programs and data from on-premises Windows to Linux environments. Expertise in ETL, reporting, and business intelligence platforms, with a strong command of SAS/BASE, SAS/STAT, SAS/MACROS, SAS/SQL, and SAS/ODS. Skilled in data extraction, transformation, and reporting using procedures like PROC REPORT, PROC TRANSPOSE, PROC MEANS, and PROC TABULATE, and generating outputs in HTML, Excel, PDF, and RTF formats. Adept at writing and debugging SAS code, performing data validation and cleaning, and managing large clinical and healthcare datasets. Experienced in statistical analysis using PROC FREQ, PROC MEANS, PROC ANOVA, and other advanced procedures. Demonstrated success in creating summary tables, listings, and graphs for healthcare analytics. Strong communication, analytical, and leadership skills, with the ability to manage innovative technologies and work effectively in challenging environments.

TECHNICAL SKILLS

SAS Tools:

SAS/Base SAS/Stat SAS/Graph SAS/SQL SAS/Access SAS/ODS SAS/Report

Statistical Tools:

SAS v 9.x SPSS R

Database:

SQL Server 2000 PL/SQL MS Access Microsoft Access Oracle Clinical, DB2, Teradata

Operating System:

UNIX Windows 2000/NT/XP

Tools:

Jupyter Notebook, Tableau, Endnote, MAVEN, ATLAS, PHPC Salesforce

Mapping Platform:

ArcGIS

Programs:

Microsoft Office Suite (Word, Excel, PowerPoint, Access and Outlook)

PROFESSIONAL EXPERIENCE

Hackensack Old Bridge Medical Center -Old Bridge, NJ March 2023 – Present

Sr. Clinical SAS Programmer

Extract, transform, and load clinical trial data from various sources into SAS datasets.

Develop SAS programs for data analysis, summarization, and visualization.

Prepare clinical study datasets according to CDISC standards, including SDTM and ADaM.

Perform statistical analyses using SAS procedures such as PROC ANOVA, PROC REG, and PROC MIXED.

Perform data validation and quality checks using PROC FREQ, PROC MEANS, and custom macros.

Create clinical study reports, including tables, listings, and figures (TLFs), using PROC REPORT and PROC SGPLOT.

Identify and resolve data inconsistencies and discrepancies in clinical datasets.

Implement CDISC standards, including SDTM and ADaM, for clinical trial submissions.

Prepare datasets and reports for submission to regulatory authorities (e.g., FDA, EMA).

Map raw clinical data to SDTM domains using SAS programs.

Generate ad-hoc and customized reports to support clinical trial activities.

Collaborate with statisticians to create analysis-ready datasets and support statistical models.

Derive analysis datasets from SDTM datasets following ADaM specifications.

Create graphs and plots using SAS procedures like PROC GPLOT, PROC SGPLOT, and PROC GCHART.

Integrate data from multiple sources for comprehensive analysis and reporting.

Develop reusable SAS macros to automate repetitive tasks and improve efficiency.

Maintain thorough documentation of programming processes, datasets, and outputs.

Test and debug SAS programs to ensure accuracy and compliance with study requirements.

Work closely with data managers, statisticians, and clinical teams to understand project requirements.

Create, maintain, and manage clinical trial databases.

Ensure the security and confidentiality of clinical trial data.

Manage metadata for clinical datasets to ensure consistency and traceability.

Adhere to SOPs and industry best practices in clinical programming.

Ensure datasets and outputs are audit-ready for internal and external reviews.

Train and mentor junior programmers on clinical SAS programming best practices.

Community Medical Center- Tom’s River-NJ March 2022 – March 2023

Clinical SAS programmer

Worked with clinical research staff to provide SAS programming support to clinical study group for Clinical Trial projects.

Assisted with analysis planning including review of table and listing mockups and analysis dataset requirements.

Validated programming output and mockups in SAP using PROC COMPARE.

Used DATA STEP to derive analysis dataset from raw dataset using define feature in SAP and Clinical Report Forms.

Used various procedures like PROC REPORT, PROC FREQ, PROC TABULATE, PROC MEANS AND PROC SUMMARY to generate various data tables, patient data listings and reports according Statistical analysis plan.

Contributed to Integrated Summary of Safety Analysis.

Created tables, graphs, and listings for inclusion in clinical study reports, and regulatory submissions and maintained existing ones by using SAS MACROS.

Ensured analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting.

Prepared detailed analysis plan from study protocol with biostatisticians.

Written customized safety and efficacy reports directing SAS output to RTF and HTML files using Output delivery System (ODS) facility.

Northwestern Medicine- McHenry, IL May 2018 – November 2022

Statistical Programmer

Worked with clinical research staff to provide SAS programming support to clinical study group for Clinical Trial projects.

Assisted with analysis planning including review of table and listing mockups and analysis dataset requirements.

Validated programming output and mockups in SAP using PROC COMPARE.

Used DATA STEP to derive analysis dataset from raw dataset using define feature in SAP and Clinical Report Forms.

Used various procedures like PROC REPORT, PROC FREQ, PROC TABULATE, PROC MEANS AND PROC SUMMARY to generate various data tables, patient data listings and reports according Statistical analysis plan.

Contributed to Integrated Summary of Safety Analysis.

Created tables, graphs, and listings for inclusion in clinical study reports, and regulatory submissions and maintained existing ones by using SAS MACROS.

Ensured analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting.

Prepared detailed analysis plan from study protocol with biostatisticians.

Written customized safety and efficacy reports directing SAS output to RTF and HTML files using Output delivery System (ODS) facility.

Advocate Medical Group- Libertyville, IL June 2015 – May 2018

Clinical SAS Programmer

Wrote SAS programs for analysis in UNIX and PC environment

Generated tables, listings, figures using PROC TABULATE, SUMMARY, REPORT, GPLOT, GCHART, DATA NULL, ODS, etc., to evaluate safety, efficacy, tolerability and pharmacodynamic effects Phase I-III clinical trials in CNS, CV, respiratory disorder, gastrointestinal, disorder, diabetes, infection, arthritis, generic drug, imaging diagnostic agent, etc.

CDISC STDM implementation in submission dataset

Validation and review of other Programs

Responsible for study CRF annotation using STDM variables and SDTM Data specification review

Generated CRF tracking and other reports

Created data files for PK analysis

Conducted multiple pooled analyses including ISS that covered various of phases and designs of imaging agent and investigational medication studies

Transformed Data and Creating Analysis Data sets referring to the specifications provided according to the CDISC standards

Produced customized and annotated SAS graphs error bar chart, box plot, error bar chart, box plot, error bar plot, survival curve, etc.

Created Modular code with Macros, wrote Macros with conditional logic, wrote Data-Driven Programs with CALL SYMPUT

Tested Categorical Data with PROC FREQ, Producing Statistics with PROC MEANS

Wrote edit checks from the Data Cleaning Plan DCP specifications

Checked values of Numeric Variables, Checked for Missing Values, looked for n Observations per subject, verified double entry and used SQL for Data Cleaning

Extracted Data from Oracle database using SAS/ACCESS, E-review, PROC SQL

Wrote Delimited and HTML files using ODS

Used PROC TTEST, PROC UNIVARIATE, PROC CHART, PROC GLM, PROC ANOVA for Relationship with Continuous dependent variables

Converted SAS datasets to Xport format

Provided SAS training to Oracle Clinical programmers

Set-up data extracts in Oracle Clinical

Education

Chamberlain University, Addison, IL - Bachelor of Science in Nursing- 2021

• Recognized on the Dean’s List – 05/2018

DeVry University, Online - BS in Healthcare Admin with minor in Health Information Management- 2017

Licensure, Certification & Skills

Registered Nurse: New Jersey and Illinois (compact license), License number – 26NR23834600

Basic Life Support (CPR – Cardiopulmonary Resuscitation) – American Heart Association

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