Resume of MRUGESH PATEL
SUMMARY OF QUALIFICATIONS:
SAS Programmer with over 7 years of experience in SAS v 8.2 and 9.x on
Windows, UNIX in Healthcare/Pharmaceutical industry.
Proficient in SAS Enterprise Guide, Base SAS, SAS/MACROS, SAS/ACCESS,
SAS/GRAPH, SAS/STAT, SAS/ODS and SAS/SQL in Windows, UNIX environment.
Programming experience with PROC Report, PROC Freq, PROC Tabulate, PROC
Plot, PROC Chart, PROC Format, PROC Compare, PROC Print. Design SAS program
to validate dataset and compare in organize manner to find discrepancy and
create flag variable for Healthcare Data.
Developed SAS programs to create and validate analysis datasets, listings
and summary tables of safety and efficacy data for Phase I- IV clinical
trials.
Worked with different clinical trials data such as demographics, Adverse
Event (AE), Serious Adverse Event (SAE), Lab, ECG, Con-drug, ECOG, Test
drug, Vital signs and so on.
Strong working knowledge in clinical trial data analysis, generating
reports and summary tables, listings and graphs as per Statistical Analysis
Plan (SAP) and protocol specifications.
Report generation using Proc Report, Proc Tabulate, Proc Print and Proc
Summary. Creating custom reports using Data _Null_ and ODS.
Experience with data extraction, data manipulation and perform statistical
analysis using various analysis procedures such as Proc Freq, Proc Means,
Proc ANOVA, Proc Univariate, Proc GLM and Proc Summary.
Good understanding of CDISC SDTM models and experience in converting legacy
data to CDISC SDTM (Study Data Tabulation Model) Standards.
Knowledge of electronic submissions in eCTD format, including ISS/ISE.
Familiar with Clinical Terminology and regulatory Guidelines. 100% Project
completion on time while meeting strict timelines and budget requirements.
Quick learner and excellent team player, ability to meet deadlines and work
under pressure.
TECHNICAL SKILLS:
SAS Tools: SAS/BASE, SAS/GRAPH, SAS/MACROS, SAS/ODS, SAS/REPORTS,
SAS/ACCESS, SAS/STAT, SAS/EG.
SAS Procs: Print, Means, Univariate, Correlation, Regression, SQL, Report,
Freq, Sort, Summary, Format, Import, Export, Transpose, Compare, Gplot and
Gchart.
Database: Oracle Clinical and MS Access.
Operating Systems: Windows 98/2000/XP/7, UNIX, Linux.
Other Technologies: Microsoft Office.
PROFESSION EXPERIENCE:
Feb'12 - June'13
HDMS
SAS PROGRAMER ANALYST
Chicago, IL
HDMS is the premier provider of healthcare decision support solutions, HDMS
empowers employers and health plans to maximize the value of their
healthcare data through powerful, specialized and customized, web-based
reporting and analysis tools.
Responsibilities:
Develop and maintain standard programs and utilities to process
healthcare claims data and prepare the data for analytical
reporting.
Read in text data file in SAS. Create new layout from scratch. Gather
requirements to create new layout.
Create and load new formats for SAS process.
Use VSS to move programs from production to test environment.
Understand complex SAS production workflow and troubleshoot it.
Create new macros and modify existing macro as per requirement.
Modify informatica process to add changes in workflow.
Create and maintain complex SAS process to ETL data to prepare for DART
(Data Analysis Reporting Tool).
Create test base to check new implementation.
Create Ad hoc programs to validate received data.
Create ad hoc to create reconciliation reports in Excel.
Environment: SAS/Text pad, SAS/Base, UNIX, VSS, INFORMATICA,
SAS/Universal viewer
Aug '11-Jan'12
United Health Group
SAS Consultant
Minneapolis, MN
United Health Group is leading Health Care Company. It provide spectrum of
products and services through operating business. It is parent company of
United Health Care and Optum.
Responsibilities:
Create access for datasets in UNIX server to extract data. Ensure all
required data has been extracted from server for process.
Create dataset with multiple records in timely manner from one
observation. Keep track of observation from original dataset to new
dataset for auditing.
Make sure to include required data elements in dataset during extraction to
compare with different datasets.
Validate all observation from datasets has been included in comparison
process. Only compare unique records from datasets with each other with
timeline to avoid false discrepancy creation.
Create discrepancy whenever a comparison of unique records between datasets
results in a mismatch for contiguous time period.
Calculate time for discrepancy from start to end period. Close out
discrepancy if it no longer exists between datasets.
Create discrepancy file to extract as per required format. Create test data
for unit testing as per requirement to match the programming.
Works with excel to extract and import dataset. Work with Access to
understand queries and other details for the creating reports in SAS with
same as process.
Environment: SAS/EG, SAS/Base, UNIX, Warehouse Reflection.
Apr '10 - May '11
SDI Health
Clinical SAS programmer
PA
SDI Health is aligned to provide innovative healthcare data solutions to
clients range from developmental healthcare companies to large
international healthcare concerns.
Responsibilities:
Extracted data from Oracle using SQL Pass through facility and generated
reports. Maintenance of large data sets, combining data from various
sources in varying formats to create SAS data sets and/or ASCII files by
using Set and Merge for generating Reports and Graphs.
Developed new or modified SAS programs to load data from the source and
create study specific datasets, which are used as source datasets for
report generating programs.
Prepared new Datasets from raw data files using Import Techniques and
modified existing datasets using Set, Merge, Sort, and Update, Formats,
Functions and conditional statements.
Created complex and reusable Macros and extensively used existing macros
and developed SAS Programs for Data Cleaning, Validation, Analysis and
Report generation.
Generated Tables, Graphs and Listings for inclusion in Clinical study
reports and regulatory submission; Participated in preparing study results
as well as ISS and ISE for FDA submissions using SAS.
Modified macros for report generation using SAS Macros as per the
statistician's requirements. Developed efficacy and safety tables including
Adverse Events table, Laboratory Shift table and Concomitant Medication
tables.
Generated summary reports, listing and graphs using procedures like PRINT,
REPORT, MEANS, FREQ, TABULATE, SQL, UNIVARIATE, GPLOT and GCHART. Wrote
programs in SAS to generate reports, creating RTF, HTML listings, tables
and reports using SAS/ ODS for report generation.
Attended project team meetings, worked with Bio-Statisticians, Data
Managers, and Clinical Research Managers as appropriate.
Environment: Oracle10g, SAS v.9.1, SAS/BASE, SAS/SQL, SAS/Macro,
SAS/STAT, SAS/Graph.
Apr '09 - Mar '10
Kendle International
Statistical Programmer
Old Lyme, CT
Kendle International is one of the most innovative, productive, and
respected scientific research analysis organizations in health care.
Primary responsibilities include the production of CDISC SDTM Compliant
datasets and specifications, summary tables, figures, listings and
statistical analyses for efficacy and safety as well as providing edit
checks, data review listings, & validation.
Responsibilities:
Worked extensively to generate SAS data sets, statistical reports, monthly
reports, listings, safety reports for cross-functional teams for Phase I to
II of Clinical Trial Data.
Worked with the Statisticians, Data managers to provide SAS programming in
analyzing Clinical Trial Data, generating final study reports, tables,
listings and graphs. Created edit check programs to find data discrepancies
in raw datasets provided by Data Management Group.
Generated tables, listings and graphs according to Protocol and Statistical
Analysis Plan (SAP) using PROC MEANS, PROC FREQ, PROC TRANSPOSE, PROC
REPORT, PROC GCHART and PROC GPLOT Procedures.
Created SAS Customized Reports using the Data _Null_ technique. SAS/STAT
procedures such as UNIVARIATE, FREQ, and MEANS were used to carry out
analyses and the SAS REPORT procedure is generally used to display results.
Used SAS ODS to produce HTML, PDF and RTF format files. Involved in
generating ISS (Integrated Summary of Safety) and ISE (Integrated Summary
of Efficacy) analysis Datasets, Tables, Listing and Graphs.
Environment: Oracle9i, SAS v.9, SAS/BASE, SAS/SQL, SAS/Macro, SAS/STAT,
SAS/Graph, SAS/Report, SAS/ODS.
May '08 - Mar '09 ZIOPHARM
Oncology
SAS Programmer NY
ZIOPHARM Oncology is an oncology-focused biopharmaceutical company that
acquires, develops and commercializes proprietary products that address the
unmet needs of cancer patients. This project involves the creation of SAS
data sets using the raw clinical data for analyzing the Pharmacokinetics,
Pharmacodynamics property of the drug, safety and efficacy reports.
Responsibilities:
Created, derived and merged and pooled datasets, listings and summary
tables for Phase-I and Phase II of clinical trials. The accuracy and
integrity of clinical data were verified by performing validation checks
written in SAS and checked for data related errors, outliers, and missing
values.
Involved in analyzing Pharmacokinetics and Pharmacodynamics Property of the
drug using PK/PD Parameters. Macros were written at various instances for
automating listings and graphing of clinical data for analysis.
Programmed edit check procedures to ensure validity of data collected
internally. Involved in validating and QC of the efficacy and safety
tables. Created SAS reports using the Data _Null_ technique and the PROC
Report for the NDA submission as per the FDA regulations and company
standards.
Environment: SAS9 (BASE, SQL, ODS, MACROS) UNIX.
Oct '07 - Apr '08
CARA Therapeutics Inc.
SAS Programmer
Shelton, CT
Cara Therapeutics is an emerging biotechnology company focused on
developing novel therapeutics to treat human diseases associated with pain
and inflammation.
Responsibilities:
Worked in Phase I & II of clinical trials for studies in Integrate Data
from wide range of sources including in-house clinical data management
systems, labs and contract research organizations and perform data
cleaning with data steps using DLM, DSM, and COMMA9. TRUNCOVER, MISSOVER
etc.
Performed data validation on the data sets and deleted repeated values
using conditional data steps such as @@, if-then statements. Designed
statistical tables, graphs, and data listings. Developed SAS macros for
data cleaning and reporting and to support routing processing.
Performed Data Analysis on the data sets using Proc Annova, Proc Mean, PROC
Univariate, Proc FREQ and PROC TRANSPOSE. Developed reports using PROC
Report, PROC Tabulate and DATA _NULL. Generated output files in text
format, HTML & PDF format using SAS ODS.
Use EXCEL and Access to import and export dataset from SAS. Use ACCESS to
excess Dataset with Queries and create same queries in SAS.
Environment: SAS9 (BASE, SQL, ODS, MACROS, IT, ETS), Windows XP/2000.
Oct '06 - Aug '07
Panacea Biotech
SAS Trainee/Programmer
India
Panacea Biotech is research base health management company and serves
internationally for the pharmaceutical and biotech industries with offices
in the US, Europe and India.
Responsibilities:
Involved in the analysis of Phase I and Phase II clinical data. Cleaning of
data using data step and SAS base Procedures. Assigned formats and labels
to the variables in analysis data sets.
Generated tables, listings and graphs according to Protocol and Statistical
Analysis Plan (SAP) using PROC PRINT, PROC REPORT, PROC TABULATE and PROC
GPLOT.
Generated summary reports and descriptive statistics. Created and applied
user defined formats to specific variables in SAS data sets. Developed SAS
programs using SAS/BASE and SAS/SQL for preparing analysis and reports from
databases.
Responsible for data validation and corrections - uploading / downloading
data. Create and extract Oracle tables from SAS and within Oracle by using
SAS/Access, SAS/SQL.
Used SAS data step functions, formats, statements and procedures like PROC
FORMAT and to map the variables to the customer's needs. Involved in
writing code using BASE SAS and SAS/Macros to extract clean and validate
data from Oracle tables.
Environment: SAS 8.2 (BASE, SQL, ODS, MACROS).
EDUCATION:
Master Of Science, Long Island University, New York.
Bachelor Of Pharmacy, Pune University, India.