PROFESSIONAL SUMMARY

Meticulous and highly accomplished SAS with over 7 years of experience in Clinical Trials data and statistical analysis; result oriented decisive leader to maintain high quality standards to meet challenges of this fast-paced, high-turn industry

Over 7 Years of experience as Sr. SAS Programmer in providing innovative solution needs in Clinical Research and Healthcare.

Extensive experience in Base SAS including SAS Macros and SAS SQL Procedures.

Expertise in creation and validation of ISS/ISE Programming, Derived datasets Programming

and TFLs Programming and very detail oriented in Programming, Study Specs review, Program

review and TFL review.

Hands on experience in working with Statisticians for analysing Clinical Trial Data and generating reports containing tables, listings and graphs in accordance with the Statistical Analysis Plan (SAP) and Standard Operating Procedures (SOPs).

Proficient at problem solving. Able to debug and resolve issues related to other people’s code.

and/or system macro code.

Understands the major bio statistical deliverables (Analysis Plan, CSR), and the process of

developing publications for external consumption (abstracts, posters, slide decks, manuscripts).

Worked in close proximity with Biostatistician in analysing clinical trial data and TFLs generation

using SAS programming; and providing inputs in SAP preparation whenever required.

Experience in coordinating with Clinical Data Management (CDM) Lead, Statistical Programming

Lead and Biostatistician for queries related to clinical study data, analysis and report generation.

Experience in extracting data from various data sources such as Oracle and Access databases, Excel Spreadsheets and flat files and creating SAS datasets

Expertise in using various SAS procedures such as Tabulate, Univariate, SQL, Freq, Means, T-Test, Compare, Sort, Transpose and Report.

Hands on experience in generating customized reports using Proc report and Data _null_.

Experience in producing RTF, PDF and HTML reports using SAS ODS.

Good understanding of Clinical Trial Phases, clinical protocols, CRF’s/Annotated CRF’s, ICH and GCP guidelines, NDA, IND, CDISC, MedDRA, 21 CFR PART 11 and familiar with FDA Electronic submission guidelines

Having knowledge with the following statistical methodologies: General Linear models - ANOVA, ANCOVA, Mixed models, t-test, F-test etc; Non Parametric methods - Binomial test, Chi-Squared test, Wilcoxon tests, and Logistic regression.

Knowledge of statistical concepts, such as p-values, rates and proportion, frequencies, confidence intervals, survival analysis, non-parametric analysis. Capable of implementing these ideas in clear, efficient SAS codes for the purpose of data analysis and reporting.

Excellent domain knowledge combined with technical skills

Strong communication skills and enjoy working in teams

Computer Proficiency

Operating System : Windows

SAS Tools : SAS/Base, SAS Advance, SAS/GRAPH

Applications : MS Excel

Professional Experience

Organization: JS Logicsoft INC (Aug, 15 – Till date)

Designation: Consultant – Senior SAS Programmer

Client : Alexion pharmaceuticals CT

Therapeutic Area : hematology

Responsibilities & Key Deliverables:

Co-ordinate with CRO for outsourced trials. Co-ordinate with the Clinical Team, Clinical Data Manager and Statistician.

Reviewed specifications for SDTM and ADAM datasets.

Performed validation of tables, listings, figures (TLF’s) using double programming and comparing the statistics and also the layout, cosmetics of the TLGs etc.

Extensively worked on validation of SDTM and ADAM datasets using double programming.

Be responsible for statistical tasks on assigned clinical trials.

Maintain efficient interfaces with internal and external customers with support of GBS management and the Protocol Programmer/Statistician.

Worked on Ad-hoc reports and Event Based Requests for clients within tight deadlines in accordance with client specifications and comments.

Make certain that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities.

Reviewed open CDISC report, Reviewer’s Guide and eSUB packages (SDTM/ADaM).

Maintain records(SDLC documentation) for all assigned projects and archiving of trial / project analysis and associated Documentation

Enhance technical skills relevant to statistics and efficient programming aspects.

Handle miscellaneous tasks as assigned by management like creation of outputs from the source datasets.

Involved in acceptance checks.

Organization: Novartis Healthcare NJ (Jun 12, – Jul, 15)

Designation: Senior Programmer

Therapeutic Area: Oncology

Role: SAS Programmer

Responsibilities & Key Deliverables:

Worked extensively in different phases of drug development in Oncology therapeutic area.

Involved in the process of generating TLG’s for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.

Locally coordinate and take responsibility for trial level programming activities (analysis

Datasets, pooled datasets, listings, tables and figures) of individual Phase I-IV clinical trials to

Support program programmers and statistician in project level activities.

Extensively worked on creation of SDTM and ADAM datasets as per NCDS standards.

Developed and reviewed specifications for SDTM and ADAM datasets as per NCDS standards.

Developed RECIST based datasets for derivation of primary and secondary endpoints.

Be responsible for statistical tasks on assigned clinical trials e.g. RAP(reporting analysis plan).

Maintain efficient interfaces with internal and external customers with support of ONC Biometrics management and the Program Programmer/Statistician.

Involved in review of mock shells, CRFs and data transfer specifications.

Make certain that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities.

Program and deliver, according to specifications, analysis datasets, pooled datasets, listings,

Tables, and figures for phase I-IV clinical trials and for pooled analysis with high quality and

Within milestones.

In consultation with the statistician, develop specifications for analysis datasets, pooled

Datasets and listings

Maintain records for all assigned projects and archiving of trial / project analysis and associated

Documentation

Enhance technical skills relevant to statistics and efficient programming aspects.

Handle miscellaneous tasks as assigned by management.

Participate in task forces/initiatives.

Client:Wyeth PA (Jan, 09 – Mid Aug, 11)

Designation: Associate SAS Programmer

Therapeutic Area: Cardiovascular/Neuroscience

Responsibilities & Key Deliverables:

Understand study documents (Protocol, eCRF, Annotated CRF and SAP).

Extract, Access and Manage clinical data from the database and create SAS data sets.

Preparing new datasets from raw data files and modify existing datasets using set, merge, sort,

and update, formats, functions and conditional statements, if required.

Involved in writing SAS codes to extract and validate clean data to analyze clinical data

(validation, analysis and report generation).

Managing data issue tracker and coordinating with CDM Lead, Programming Lead and

Biostatistician for queries related to clinical study data, analysis and report generation and final

delivery.

Involved in development, validate, test and enhancements of SAS Programs to generate TFLs

based on SAP.

Implement consistent, efficient and quality processes to meet timelines and deliverables

according to requirements and SOPs.

Perform edit checks, QC checks for TFLs produced and complete the QC documentation.

Write and validate SAS programs for ad-hoc/exploratory analysis.

Generate/Update/Modify SAS listings as per the new requirements.

Involved in performing Interim Analysis as directed by client.

Ensure overall consistency of a project including macro definitions, debugging programs, and

documentation.

Ensure all programs are in compliance with SOPs and project specific guidelines (as mentioned

in SAP).

Maintain project directories on systems, including ensuring that final SAS output is in the

correct directory and that all interim programs and output are deleted at the completion of the

project.

Academic Credentials

Master of Computer science(Information Systems) from Andhra university, Visakhapatnam.

Bachelor of computer science from Nagarjuna University.

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