Data Customer Service

PROFESSIONAL SUMMARY

Over all *+ years of Experience in working with SAS 8.2/ 9.2/ 9.4 in Unix, Linux & windows Environments.

Good Knowledge of different phases (phase I to IV) of Clinical trials in various therapeutic areas like Oncology,

Pulmonary, Cardiovascular and Epidemiology.

Expertise in analyzing and coordinating clinical trial data generating Tables, Listings and Graphs.

Experience in producing HTML, RTF and PDF formatted files using SAS/ODS.

Experienced in the analysis, design, and development and testing of clinical applications in the

Pharmaceutical, and CRO Industries.

Experienced in SAS Macro Language.

Reviewing Clinical Study Protocol, CRF forms, and Data Analysis Plan documents.

Experience in modeling for risk rating, and performing various business analyses like Product performance,

Customer behavior, and Market performance

Proficient with SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS MACROS and SQL.

Responsible for developing and modifying reports based on Statistical Analysis Plan, or creating Ad Hoc

reports by using REPORT, and SUMMARY and provided descriptive statistics using MEANS, FREQ, and

UNIVARIATE.

Worked on Data Management SAS DATA step processing, PROC SQL for data extraction, write datasets,

Report, generate list for phase I/III clinical trials and use of PROC REPORT, DATA NULL, SAS Macro

processing.

Specialization in Data Modeling and experience in designing phase of Software Development Life Cycle.

Well versed with Clinical Trial processes such as Randomization Process, Trial execution, Statistical Analysis,

Data capture, Data cleaning, Data Management and Reporting.

Developed tables, and figures, for clinical studies and prepared regulatory documents for FDA submissions.

Proficient in developing Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) by

combining several studies.

Collaborated with Clinical Data Management to annotate CRFs with standardized variables and formats using

Proc Datasets, Proc Formats.

Experience in providing Clinical Study Reports, compliant with FDA guidelines in 21 CFR Part 11 for electronic

submissions.

Working knowledge of FDA regulations, ICH Guidelines and GCP requirements.

Ability to communicate and work with persons at different levels of management and collect requirements

from users.

Ability to handle multiple tasks and work independently as well as in a team.

Willing to relocate: Anywhere

Authorized to work in the US for any employer

PROFESSIONAL EXPERIENCE

Clinical Statistical Programmer (August 2013 – June 2015)

Lodhi Maternity and General Hospital, Hyderabad, India

Therapeutic Area: Oncology, Respiratory studies

Boston Scientific is a pharmaceutical company. Worked on clinical trial safety and efficacy data which is a

phase II Double blind, Double dummy DSMB study. Followed CDISC SDTM standards and Prepared SDTM

and ADaM datasets. Generated Summaries and listings as well.

Created and maintained SAS Datasets extracted from Database.

Worked with different clinical trials data, Demographic, Adverse Event (AE), Serious Adverse Event (SAE),

Laboratory, and Physical examination.

Produced analysis datasets for generating Reports.

Created Tables, Listings, Graphs and customized reports using various procedures PROC Report, PROC

Tabulate, Data _null _ and PROCGPLOT.

Involved in creation of CRT datasets transport files and associating documentation as a part of FDA

submissions

Involved in writing the SAS code to help in the process of Quality control by implementing various statistical

procedures PROCFREQ, PROCMEANS, PROCUNIVARIATE and PROCSUMMARY, PROC Transpose,

PROC SQL and PROCPRINT.

Wrote SQL Queries to debug duplicate values and missing values.

Used the SAS Macro facility to modify existing departmental macros and to replace repetitive codes.

Extensively used SET, MERGE, UPDATE statements and PROC SQL for adding new variables or

observations, creating subsets or modifying datasets.

Produced quality customized and ad hoc reports by using PROC TABULATE, REPORT and SUMMARY and

also provided descriptive statistics using PROC MEANS, FREQ.

Produced RTF, PDF and HTML formatted files using SAS/ODS.

Documented data sets using specifications worked out in conjunction with senior manager.

As a clinical data associate performed UAT on EDC Software and reported the edit checks.

Performed Quality Control, Data Validation and Edit Checks using various Procedures and Macro facility.

Wrote SAS Programs for the edit checks that were detected manually.

Performed validation of SAS-generated output (tables, listings and graphs) via independent programming.

Also performed QC checking and validation of SAS programs written by other programmers.

Participated in team meetings to discuss best programming practices. Established and maintained sound

working relationship and effective communications within Biostatistics, Statistical Reporting, and the Data

Management group.

Environment: SAS v9.1, SAS/BASE, SAS/GRAPH, SAS/MACROS, SAS/SQL, SAS/ODS, SAS/ACCESS

SAS Programming (December 2012 – August 2013)

Pragathi Agencies, Hyderabad, India

Performed data analysis, statistical analysis, generated reports, listings and graphs using SAS.

Responsible for providing SAS programming and analysis support for several studies in close collaboration with Statisticians.

Developed, modified, validated and implemented SAS programming as per Statistical Analysis Plan (SAP).

Designed and developed SAS macros and other utilities to expedite SAS programming activities.

Generated reports in SAS, creating RTF, HTML listings and tables using SAS ODS for ad-hoc report generation and analysis.

Created Dynamic Macro arrays by SQL and with data step programs.

Creation of reports to support ongoing evaluation of retention programs.

Interact with other departments such as Clinical Operations, Project Management, and Data management to ensure a high level of client satisfaction through successful execution of projects.

Involved in standardizing reporting procedures for graphical and tabular reports.

Created reports in the style format (RTF, PDF and HTML) using ODS statements and PROC TEMPLATE. Used DBLOAD procedure to load data into the database effectively prepared and published various performance reports and presentations.

Worked with complex datasets to extract customized reports using PROC SQL, PROC FREQ, PROC SORT, PROC REPORT, PROC MEANS for creating a preferred list of customers as per the given requirements from business analysts.

Performed complex statistical analysis using PROC MEANS, PROC FREQ, PROC SUMMARY, PROC SORT, and PROC SQL.

Extensively used the SET, UPDATE and MERGE statements for creating, updating and merging various SAS data sets.

Performed Statistical analysis on difference kind of data and generate the reports and analysis on patient, physician, Bill Review, audits and claims data.

Performed data analysis, created reports using BASE SAS, macro & SAS reports with the help of default procedure.

Experience in developing and maintaining statistical documentation, including description of statistical methods, SAS programs, results, and discussion

Participated in review process of study documents such as CRF, edit check specifications, and database design specifications written by Data Management.

Environment: SAS 9.2, Base SAS, SAS Graph, SAS Report, SAS ODS, and SAS Stat.

SAS Programming/Internship (January 2012 - August 2012)

Pragathi Agencies, Hyderabad, India

Produced quality customized reports by using PROC TABULATE, PROC REPORT, PROC SUMMARY, PROC MEANS, PROC FREQ.

Prepared clinical data listings and summaries for statistical analysis and analysed clinical data using SAS system.

Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/BASE and SAS/MACRO facility. Excel for further analysis using SQL pass-through facility.

Worked with the marketing team and analysed marketing data using SAS tools to generate reports, tables, listing and graphs.

Excellent leadership, analytical and problem-solving skills.

Attended several meetings with Senior Programmer and Statistician.

Ran weekly and monthly reports using SAS Macros.

Generated modifiable SAS code using SAS/ BASE and SAS/ MACRO facility.

EDUCATION

Central Michigan University, Mt. Pleasant, MI

Masters of Science: Health Services Administration (Graduated May 2017)

Coursework: Health planning, Financial health services aspects, Organizational dynamics and human behaviour, Financial analysis, Health services administration, Statistical programming and data management.

Overall GPA: 3.3/4.0

Manipal University, Manipal, Karnataka, India

Bachelors of Pharmacy: Pharmacy (Graduated Nov 2012)

Coursework: Anatomy & Physiology, Biochemistry, Pathophysiology, Pharmacology, Pharmaceutical management.

SUMMARY OF SKILLS

Technical skills

Operating System: Windows, UNIX

Utilities: MS-Office

SAS Tool: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/STAT, SAS/GRAPH SAS/ACCESS, SAS/CONNECT and ODS etc.

SAS Procedures: Import, Export, Format, Tabulate, Report, Summary, Sort, Print, Contents, Append, Copy, Rank, Means, Univariate, Transpose, Gplot, Gchart, Datasets, Compare etc.

Experience in SAS enterprise guide and worked on SAS University edition.

Administrative skills and other skills

Proficient with a variety of office-related software packages, including: Word, Publisher and WordPerfect Office

Strong written communication skills and confident with professional written communication including client letters, e-mail, memos, reports, and agendas

Maintained positive interpersonal relationships with clients and provided detailed information and thorough follow-up for agency director

Trained new staff and servers regarding best practices for customer service applications.

Competent with analysis software for quantitative data and qualitative data.

Reviewed the results of testing, simulation and data.

Resolved business issues related to business role execution.

Proficient with Microsoft word, Microsoft Office.

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