SUMMARY

• Over 7+ Years of experience in using SAS for programming and reporting in pharmaceutical industry.
• Strong experience in Base SAS, SAS/MACROS, SAS/ACCESS, SAS/CONNECT, SAS/GRAPH, SAS/STAT, SAS/ODS, SAS/CDI and SAS/SQL in Windows.
• Experience in transforming data in various formats (excel, CSV, ASCII) into SAS datasets.
• Excellent command in producing reports employing various SAS procedures like Proc Report, Proc Tabulate, Proc Mean, Proc Freq, Proc Univariate, Proc Transpose, and Data NULL etc.
• Strong experience using SAS/GRAPH to produce Graphs by employing SAS procedures such as Proc GPLOT and Proc GCHART.
• Exceptional ability in problem solving, data analysis, complex reports generation with macro and data transfer between different environments.
• Knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM), Analysis Dataset Models (ADaM).
• Good understanding of Clinical Trial Phases, clinical protocols/ CRF’s/Annotated CRF’s, ICH and GCP guidelines, NDA, IND, MedDRA, 21 CFR PART 11. Familiar with Electronic submission guidelines to FDA.
• Excellent communication, interpersonal skills with strong analytical and problem - solving skills. Ability to learn quickly and take up new tasks and responsibilities. Can work effectively in cross-functional team environments.
• Good team player with excellent technical and interpersonal skills. Pro-active, self-motivated and able to work independently as well as in team.
• Experienced in producing RTF, PDF, and MS Excel formatted files using SAS ODS facility.
• Created SAS data sets and generated listings, Analysis Data Sets (ADAMS), graphs and tables (TLG) as per Statistical Analysis Plan (SAP), also performed validation of the CDISC Models.
• Experience in data cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset.
• 100% Project completion on time while meeting strict timelines and budget requirements.

TECHNICAL SKILLS

SAS Tools: SAS /BASE,SAS /Macros,SAS /STAT, SAS/GRAPH, SAS/SQL,SAS/ODS.

SAS Procedures: PROC Report, Print,Freq, Means, Summary, Univariate, SQL, Sort, Transpose Contents, Options, Import, Export, Format, SAS Macros etc.

Operating Systems: Windows (2000, XP, 7, 11), UNIX.

Applications: MS Office 365, MS PowerPoint, MS Access, MS outlook,SAS /Add-in

Databases: MS SQL Server,Oracle, MS-Access.

PROFESSIONAL EXPERIENCE

Confidential, NJ

Senior Statistical Programmer

Responsibilities:

• Worked with Pfizer and had good hands-on experience with Cdars environment.
• Performed QC of derived datasets, TLG’s and coded programs and involved in Data Validation.
• Validation of Adam datasets as the project is nearing submission.
• Created Adhoc reports using the SAS procedures and created reports using ODS statements and Proc Template to generate different output formats like pdf and excel.
• Verified the accuracy and integrity of data by performing validation checks written in SAS and investigate data related errors, outliers, and missing values.

Confidential, Waltham, MA

Senior Clinical SAS Programmer

Responsibilities:

• Worked with statisticians in analysing the Clinical Trial Data, generated reports, tables, listings and graphs using SAS in accordance with the Statistical Analysis Plan (SAP) and departmental guidelines.
• Created reports for online and batch applications for various servers.
• Modified data using SAS/BASE and Macros.
• Understanding and using departmental utilities, processes, and procedures where applicable.
• Involved in publications, programming, and testing of utility macros for standard reports and validation.
• Involved in analysis of Phase I, II and III clinical trials.
• Created SDTM datasets and ADAM datasets according to CDISC standards.
• Prepared graphs using the modified data for business analysis.
• Produced Safety reports in PDF format.
• Worked with Data management team, investigating data issues and solving technical problems.
• Performed QC of derived datasets, TLG’s and coded programs and involved in Data Validation.
• Performed program documentation on all programs, files, and variables for future reference.
• Programmed all study-specific edit checks and review listings.

Confidential, San Francisco, CA

Senior Statistical Programmer

Responsibilities:

• Created, derived, and pooled datasets, listings, and summary tables.
• Verified the accuracy and integrity of data by performing validation checks written in SAS and investigate data related errors, outliers, and missing values.
• Developed and executed edit check programs according to specifications provided by data management operations for purposes of database verification.
• Involved in managing phase II and III clinical trial data in the respective projects.
• Used SAS SQL Pass through facility and Libname facility to import and create datasets from database.
• Developed and executed Proc SQL queries for merging, concatenating, and updating large volumes of data.
• Used Base SAS (MEANS, FREQ, SUMMARY, TABULATE, REPORT etc.) and SAS/STAT procedures (REG, GLM, ANOVA, UNIVARIATE etc.) for summarization, Cross-Tabulations, and statistical analysis purposes.
• Created complex and reusable Macros for various instances for automating listings and graphing of data for analysis.
• Created Adhoc reports using the SAS procedures and created reports using ODS statements and Proc Template to generate different output formats like pdf and excel.
• Created SDTM datasets according to CDISC standards using Base SAS and validated using validation tools.
• Collaborated with Data Management to annotate raw data with standardized variables and formats using Proc Datasets, Proc Formats.
• Performed data extraction from various repositories and pre-process data when applicable.

Confidential, Philadelphia, PA

Clinical SAS programmer

Responsibilities:

• Involved in managing randomized phase II and III clinical trials data.
• Extracted data using SQL Pass through facility and generated ad-hoc 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, Update, Formats, Functions, and conditional statements.
• Extensively used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation. Tested and debugged existing macros.
• Generated Tables and Listings for inclusion in Clinical study reports and regulatory submission.
• Participated in preparing study results as well as ISS, IND and NDA application for FDA submissions using SAS.
• Developed safety tables including Adverse Events table, Laboratory Shift table and Concomitant Medication tables.
• Attended project team meetings, worked with Biostatisticians, Data Managers, and Clinical Research Managers as appropriate.
• Gone through the documentation like study protocols, SAP's, CSR etc.,
• Generated derived data sets for the statistical analysis as per SAP.
• Got a good understanding of Clinical Trial Phases, clinical protocols/ CRF’s/Annotated CRF’s, ICH and GCP guidelines, NDA, IND, MedDRA, 21 CFR PART 11.