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RANGS - CLINICAL SAS PROGRAMMER_CERTIFIED

[email protected]

Location: Piscataway, New Jersey, USA

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Visa: H1B

Employer : [email protected]; [email protected]; (609) 778-4215 ext 1000 RANGS Statistical Programmer| Piscataway, NJ 08854 Summary Over 5 years of professional experience as Clinical SAS programmer with strong emphasis on analysis of Clinical Trial projects in Pharmaceutical, CRO and Health care industries. Ability in creation of analysis datasets, generating TLG s with statistical summary of clinical trials data and programming support to Phase I, II, III Clinical studies in multiple Therapeutic areas. Strong understanding and Experienced in CDISC models like Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM) and involved in the process of generating datasets and TLG s for ISE (Integrated Summary of Efficacy) and ISS (Integrated Summary of Safety) for FDA submission and other Regulatory Agency Standards. Experience in reviewing Define.xml. Proficiency in SAS/BASE, SAS/STAT, SAS/MACROS, SAS/SQL, SAS/GRAPH and SAS/ODS in Windows and UNIX environments. Successfully managed responsibilities for extracting, storing, and manipulating data by Proc Datasets, Proc SQL, Formats, Informats, Merging, Arrays and Proc Transpose. Experience in generating Reports employing various SAS data steps (i.e., DATA _NULL_) and Proc steps such as PROC REPORT, PROC TRANSPOSE, PROC FORMAT, PROC MEANS, PROC FREQ, PROC TABULATE, etc. Experience in conversion of SAS datasets to various file types including HTML, Excel, PDF, RTF formats using SAS/ODS and Data _Null_ to generate Ad-hoc and Customized reports. Effective in writing, editing, and debugging code using SAS/BASE and SAS/MACRO and performed data validation, data cleaning using statistical procedures like PROC FREQ and PROC MEANS. Substantial experience in managing and analyzing large volume Clinical and Healthcare Data. Skilled in generating summary tables, listings and graphs using PROC REPORT, PROC GCHART, PROC SGPLOT and PROC GPLOT. Proficient in using SAS procedures like PROC FORMAT, PROC FREQ, PROC MEANS, PROC SUMMARY, PROC REPORT, PROC TRANSPOSE, PROC TABULATE and PROC SQL. Experience in using statistical procedures like PROC FREQ, PROC MEANS, PROC LIFETEST, PROC MIXED, PROC GLM, PROC TTEST, PROC UNIVARIATE and PROC ANOVA. Own excellent communication, analytical and time management skills, with capability to manage innovative technologies and situations and an ability to lead, manage and work in challenging environments. Certification Microsoft SQL Server 2019 SAS Certified specialist: Base Programming Using SAS9.4 Skills And Ability Analytical Skills: Data Mining, Data Engineering, Database Management, Data Presentation. Business Intelligence: SAS Management Console, SAS Enterprise Guide, SAS Data Integration Studio, SAS Information Map Studio, SAS Web Report Studio. Management Skills: Project Analysis & Planning. Soft Skills: Creativity, Leadership, Teamwork, Relationship Building, Interpersonal Communication, Time Management, Problem-Solving, Organizational, Meticulous. Technical Skills SAS Tools: SAS 9.4, SAS 9.1, SAS 9.2, SAS 9.3, SAS/Base, SAS/SQL, SAS/Macro, SAS/Stat, SAS/Connect, SAS/ODS, SAS/ACCESS, SAS/ETL, SAS /Graph, SAS/OLAP Server, SAS BI platform, SAS EG, SAS EBI, SAS add-in MO, SAS WRS. Databases: Oracle, Excel. Development Tools: Microsoft Office 365 (Excel, Word, PowerPoint), MS Access, Database Management. Operating Systems: Windows XP, Vista, 7,8,10,11 Mac OS, Linux. Working Experience Sarah Cannon Research Institute. Nashville, TN Biostatistician (May2023 to Present) Responsibilities Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Worked on Creation and review of programming specifications CDISC (SDTM and ADaM). Performed CDISC (SDTM and ADaM) Production and analysis of safety and efficacy of dataset. Performed quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM and ADaM datasets. Developed and validated Tables, Listings and Graphs. Create adhoc reports and electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision. Creating and executing SAS edit check and LNR programs. Validating edit check programs using standard validation practices and processes. Creating, validating, and executing SAS programs and macros. Provide programming support within multiple studies/projects in various study activities with timely and high-quality programming deliverables in assigned tasks and projects. Collaborator with excellent communication skills and experienced working with stat programmers, statisticians, and data management personnel. Reata Pharmaceuticals, Inc. Contract Statistical programmer (March2021- April 2023) Responsibilities The project involved data analysis and SAS programming for Phase I III clinical trials studies. Involved in mapping, pooling, and analysis of clinical study data for safety and efficacy. Extracting the data from various internal and external databases (Oracle, Excel spreadsheets using SAS/ACCESS, SAS/INPUT. Performed quality control for safety and efficacy datasets according to CDISC SDTM and CDISC ADAM standards. Developed SAS programs to generate customized displays of descriptive and inferential statistics for categorical, continuous, and time-to-event endpoint using various statistical procedures including GLM, MIXED, LIFETEST, PHREG, LOGISTIC, and FREQ. Performed mapping, creating, and validating SDTM dataset including DM, DS, EX, MH, LB, VS, AE. Performed SAS programming and generated analysis for Phase II to III clinical trial studies. Wrote and validated SAS programs to generate tables, listings, and figures for study reports and analysis datasets. Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). Creating dataset and Reporting for PK, PD. Developed SAS programs to generate customized displays of descriptive and inferential statistics for categorical, continuous, and time-to-event endpoint using various statistical procedures including GLM, MIXED, LIFETEST, PHREG, LOGISTIC, and FREQ. Generated TLGs from analysis datasets including ADSL, ADLB, ADAE, ADRS, ADTTE, ADEX. Participated in preparing and reviewing submission packages including define.xml, transport files and Reviewers Guide. Cartesian Therapeutics Contract statistical programmer (December 2018 March 2021) Responsibility The project involved data analysis and SAS programming for Phase I III clinical trials for Oncology studies. Involved in Phase II and III of clinical trials and was responsible for creating, testing, and maintaining SAS programs for clinical studies according to company standard procedures. Provided firsthand support to access, extract, transform, review, analyze, and submit data for multiple studies and clinical development programs. Experience in writing mapping specification for SDTM conversions with clear mapping comments, derivation logic. Developed new and modified SAS programs to load data from the source and create study specific datasets, which are used as source datasets for report generating programs. Generated Tables, Graphs and Listings for inclusion in clinical study reports and regulatory submissions by extensively using Merge, SQL Joins and restructured the data in SAS using PROC Transpose and creating analysis datasets. Worked with Lead Programmer to analyze the report requirements and collaborated extensively with statisticians and other programmers in analyzing data and generating analysis datasets, listings, tables, and graphs. Extensively used BASE SAS, SAS/STAT and SAS/MACROS for creating and modifying datasets and generating reports. Extensively used Data _Null_ to generate Ad-hoc and Customized reports. Performed data cleaning using data step and SAS procedures. Proficient in PROC MEANS, PROC FREQ, PROC UNIVARIATE, PROC TRANSPOSE, PROC LIFETEST, PROC SGPLOT, PROC FORMAT, SAS functions and merging techniques. Performed code review, verified that the specifications were followed, Validate and document SAS macro library. Ensured Analysis Data and Programming Code meets regulatory and company standards and are consistently structured to permit efficient programming and reporting. ProtoMed BioSciences, Inc. Contract Associate statistical programmer (December 2015 December 2018) Responsibilities Performed SAS programming and provided analysis support for Phase II to III clinical trial studies. Wrote and validated SAS programs to generate tables, listings, and figures for study reports and analysis datasets. Performed quality control for safety and efficacy datasets according to CDISC SDTM and CDISC ADAM standards. Developed SAS programs to generate customized displays of descriptive and inferential statistics for categorical, continuous, and time-to-event endpoint using various statistical procedures including GLM, MIXED, LIFETEST, PHREG, LOGISTIC, and FREQ. Created pooled datasets from six studies and integrated datasets and table/graphs for ISS/ISE and controlled quality of pooled datasets. Reviewed submission package (Define.xml, aCRF, Reviewer s guide, XPT files). Participated in preparing and reviewing submission packages including define.xml, transport files and Reviewers Guide. Generated TLGs from analysis datasets including ADSL, ADLB, ADAE, ADRS. Keywords: business intelligence active directory trade national microsoft Missouri New Jersey Tennessee