Experience

Veristat

• United States
• Research Services
• 300 - 400 Employee

• Lead SAS Programmer

  • Jul 2018 - Present

  • Worked on End to activities of Protocol that includes SDTM mapping, ADaM datasets creation and TFLs programming. • Written Specifications and involved in Production and QC side of programming CDISC datasets including SDTM and ADaM. • Worked on both Safety and Efficacy programming. • Participated as required at all meetings, discussions and activities covering aspects of Statistical Reporting on trial/project level activities with CDMA, Biostatistician, Clinical trial manager and clinical program Manager • Extracted data from Oracle; worked on the raw data and created analysis data sets according to CDISC SDTM standards. • Worked on Pancreatic Cancer and Lung Cancer indications from Mapping to Reporting the Tumor data with following RECIST criteria. • Annotated the CRF (Case Report Form) hard copy as per the need identified LABELS, TYPE & FORMAT and mapped them with the variables from the raw data sets. • Created complex and reusable Macros, used existing Macros, developed SAS Programs for Data cleaning, Data validation, Data analysis and Report generation. • Analyzed and communicated with medical team members and other department stake holders. • Analyzed and commented on study documents such as SAP, protocol • Created Utilities and reusable Macros and extensively used existing macros and developed SAS Programs for Data Cleaning, validation, analysis and Report generation. Tested and debugged existing macros. • Created comparison programs for datasets and TFLs which helps to generate all log files in to single file which increased efficiency. • Trained and guided the new junior level programmer and explained them about Gilead Architecture, Macros and other question they might had. Show less



Accenutre

• Kansas City, Missouri Area

• Sr, SAS Programmer

  • Jul 2017 - May 2018

  Worked on Data Analysis of Phase II and Phase III Clinical trials on oncology studies, responsible for providing the biometrics team with programming support and producing safety and efficacy tables. • Developed analytical strategy to determine campaign effectiveness including creation of test plans, identification of KPIs based on marketing objectives and formation of detailed analysis plans • Created SDTM and CDISC datasets for phase I studies. Read in and reconciled electronic data with the CRF. • Developed tables listing and graphs (TLG) necessary for developing Clinical Trial Report (CTR) and Analyses Data Set (ADS) • Actively involved with data management team and statistician to analyze clinical trial data and to program integrated summaries (ISE and ISS), FDA, IND, submissions • Wrote specifications for SDTM dataset creation. • Performed QC of datasets, DDDs, a CRF to ensure their accuracy and that they meet the client specifications • Resolved various data issues by proving edit check programs • Modified standard programs to generate data sets for statistical data analysis, generate listings, summaries, tables, graphs and reports for analyzing clinical trial data results in compliance with relevant SOPs as per SAP. • Formatted HTML, XML, RTF and PDF reports, using SAS Output Delivery System (ODS). • Created datasets by combining different data sets using dataset merging techniques for SAS/BASE and using different inner and outer joins in SAS/SQL • Developed routine SAS macros and used departmental macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones. Show less



Quintiles

• Raleigh-Durham, North Carolina Area

• Sr. SAS Programmer Analyst

  • Dec 2015 - Jun 2017

  • Worked as a SAS programmer to analyze initial data sets and create listings and Tables (TLs) for clinical trials. Using Proc Freq, Proc Tabulate, Proc Report, Data _null_ • Modified existing datasets using Set, Merge, Sort, Format Techniquesand DATE, TIME Functions in accordance with CDISC and SDTM standards. • Worked on different clinical data such as adverse events (AE), serious adverse events (SAE), demographic (DM), vital signs (VS) • Converted MS-Word documents and EXCEL tables into SAS data sets. • Conducted documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR) and other regulatory compliance. • Worked on Pivot tables and VBA to write macros in Excel. • Generated analysis datasets and performed statistical reports as per SAP and DDT • Responsible for creation of Analysis/Submission datasets using set, merge, sort, update, format procedures/statements • Extensively involved in Clinical Data Analysis and preparation of SAS datasets, reports, tables, 1listings, graphs and summaries according to the Standard Operating Procedures (SOPs) and departmental guidelines. ● Worked with statistical quality assurance group and program validation for each project. Responsible for cleansing, formatting and loading the data into the database, Microsoft SQL server ● Expert in Creation of SDTM domain specifications and applying Mapping logic ● Validated other programmers code when asked for ● Generated HTML, PDF and RTF reports as per the requirements. Show less



Cognizant

• United States
• IT Services and IT Consulting
• 700 & Above Employee

• SAS Programmer

  • May 2013 - Jul 2015

  • Performed statistical Analysis, created TLFs using SAS procedures such as Proc Report, Proc Tabulate, Data _null_, and Proc Freq • Created SDTM data specification tables with reference to CDISC standards • Worked on clinical trials data such as Demographics (DM),Vital Signs (VS), Disposition (DS), Adverse Events (AE), Physical Examinations (PE), and Laboratory (LB) • Created CRT’s (Case Report Tabulations) using CDISC standards for submissions to the FDA. • Produced SDTM and ADAM data sets by combination of two datasets in either SAS/BASE (merge by)or SAS/SQL (outer and inner join) • Worked on SDTM data mapping and confirmed the variables according to the variable • Created complex and reusable Macros and extensively used existing macros and developed SAS Programs for Data Cleaning, validation, analysis and Report generation. Tested and debugged existing macros • Created Macro and SAS programs to import external raw data file (EXCEL, Access, Oracle) in SAS environment • Used SAS Procedures like Proc Print, Proc Means, Proc Freq, Proc Summary, Proc Sort, Proc Transpose, Proc SQL for generating reports • Was responsible for generating E submission support files (PDF files) for monthly reports • Generated Analysis Datasets with the derived variables and performed analysis on the data as per the data definition table (DDT) and statistical Analysis Plan (SAP) • Attended team meetings and discussions, with team members, biostatisticians and data managers • Extensively worked on Data mapping from Existing Raw data to CDISC SDTM Standard and review CRFs (Case Report Form) to ensure consistency withprotocol and adequacy in collecting data to meet objectives defined inprotocol. • Conducted documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR) and other regulatory compliance. • Expertise in applying mapping logic and Involved in creation of CDISC SDTM Domains Specification and DataDefinition Documents Show less