Lead Programmer on a Phase I/II Safety, Tolerability, Pharmacokinetic and Pharmacodynamics
Study for Parkinson's Disease
• Validation Programmer on multiple Phase I studies for Safety, Tolerability, Pharmacokinetic and Pharmacodynamics for Obese Patients
• Lead/Validation Programmer on multiple Phase I studies for Safety, Efficacy, and Pharmacokinetics for Constipation Patients
• SAS program creation for the following tasks: o ADaM and SDTM Dataset Creation o ADaM and SDTM Dataset Validation o Create Tables, Listings, and Figures according to SAP o Validation of Tables, Listings, and Figures o Data Reconciliation
• Use Pinnacle 21 for validation and creation of SDTM, ADaM, and Define files
• Annotation of CRFs
- CLINICAL SAS PROGRAMMER at Innovative Analytics
- BIOSTATISTIC INTERN at Dorothy A. Johnson Center for Philanthropy
- GRADUATE ASSISTANT at Grand Valley State University
- STATISTICAL INTERN at ProCare Systems
3 years, 7 months at this Job
- M.S. - Biostatistics
The Project is to create mapping sheets which are used to map raw data as source to SDTM as target. SAS based tool is used to perform this mapping to enable Study Onboarding in Information Integration Platform Responsibilities:
• Interacting with the business users to gather requirements and understanding of business process.
• Analyzing the data model, writing scripts to generate test data sets from identified sources.
• Write SQL, PL/SQL code to create test data based on the data model and masking the data for testing purpose.
• Creating documents such as Requirements and Design, Traceability Matrix of Requirement and Design, Test case and test case summary report, Installation and Verification Instructions, Operational System Instructions, Standard Operation Procedures, Troubleshooting guide and User manual.
• Designing the Data Movement and Transformation architecture for Eli Lilly similar to the existing system for minimum impact and change at the end user level.
• Analyzed and interpreted data from various sources organized and summarized data for analysis.
• Experienced in generating reports for Pharmaceutical domains; have good understanding in CDISC(SDTM).
• Critically evaluates information gathered from multiple sources, reconciles conflicts, and decomposes high-level information into details.
• Generate summary tables and TFLs
• Improved and updated the SAS programs used in the process
• Proof of concept (POC) developed to validate proposed solution and reduce technical risk at initial stage of project
• Worked on Technical Solution for data processing and implementation of Functional requirement.
• SAS Utility/Macro creation for global use, involved in Coding analyzing, Report generation and testing programs using SAS/Base, SAS/Macro and SAS/SQL to the Client requirements.
• Thorough understanding of Clinical Data and multiple source system like IMPACT, eCTS, eDC, CLRM Lab and Sample Logistic Environment: PL/SQL, XML, Databases, Oracle, Teradata, Oracle, MS office.
- Clinical SAS Programmer at Eli Lilly
- Technical Lead at GlaxoSmithKline
- Clinical SAS Programmer at Pfizer
4 years, 5 months at this Job
- Bachelor of Technology - Technology
- Sr Clinical SAS Programmer/Analyst at PPD Development
- SAS Developer at HDMS
6 years, 2 months at this Job
- Master's - BioTechnology
MMS is a global clinical research organization that supports the pharmaceutical, Bio tech and medical device industries with a proven scientific approach to complex regulatory submission challenges. Responsibilities:
➢ Worked with data management in reviewing protocol, CRF and generated edit check listings.
➢ Generated data review listings for Quality and medical monitors.
➢ Performed data cleaning by analyzing and eliminating duplicate and inaccurate data using PROC FREQ, PROC UNIVARIATE, and macros in SAS.
➢ Involved in annotating case report form (CRF) while creating SDTM specifications CDISC-SDTM Meta data.
➢ Generated and validated SDTM and ADaM datasets as per CDISC standards.
➢ Involved in developing, testing, tables, listings and graphs programs according to study specific mock shells and SAP.
➢ Developed and used SAS Macros programs to generate tables and listings.
➢ Extensively used SAS reporting procedures like PROC REPORT, graphic procedures like PROC GPLOT and PROC LIFETEST for survival analysis.
➢ Generated ADHOC reports using the SAS procedures, ODS pass through facility and PROC TEMPLATE to generate output in different formats like HTML, PDF and RTF.
➢ Prepared data for FDA submission as per CDISC submission standards and guidelines.
➢ Used PROC COMPARE to conduct quality control checks on datasets, tables and listing
- Clinical SAS Programmer at Johnson & Johnson, NJ
- SAS Analyst at ARASOFTEC Inc
1 year, 6 months at this Job
Role and Responsibility:
• Worked on Clinical Trials data like Demographic data, Adverse Events (AE), Serious Adverse Events (SAE), laboratory data (LB), Physical Examination (PE) and vital signs (VS).
• Worked on generating raw datasets on CDISC SDTM standards and analysis datasets on ADAM Standards.
• Good understanding of CDISC concepts and control terminology for SDTM IG 3.1.1 and 3.1.2 and ADAM IG 1.0 and 2.0
• Created SDTM datasets for Patient narratives.
• Created Patient narratives and generated .XML outputs for FDA regulatory submissions.
• Validated the edit check program and the reports for quality control process.
• Reviewed statistical analysis plan, mock-up's/shells/templates, provided comments as needed.
• Familiar with updating mock-up as per new study design.
• Referring the statistical analysis plan (SAP), analysis dataset specification was developed and developed analysis dataset programs.
• Validated and maintained status on quality control document for the client. Project 2: Role and Responsibility:
• Developed Specifications for analysis datasets as per company standards.
• Involved in creating specifications documents for SDTM and ADAM using annotated CRFs, SAP, mock-shells and Implementation guide.
• Created several domains in CDISC i.e., both SDTM and ADAM datasets on production side as well as validation side using specification.
• Used SAS/ACCESS to extract data from Oracle and other relational databases for analysis.
• Prepared new datasets from raw sets files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, Formats, and Functions.
• Developed and customized reports using PROC REPORT, PROC SORT, PROC FREQ and PROC MEANS and DATA NULL
• Created edit check specifications and documented them.
• Validated the edit check program and the reports for quality control process.
• Developed Macros to generate ad hoc reports weekly, monthly or on a specified cut date.
• Defining, Manipulation, Controlling and Reporting/Storage Query Language of Clinical Data by using PROC SQL
- Clinical SAS Programmer at Freelancing
- at ACNielsen - World's best Market Research Company
- Best Performing Team Member at Continental US
- SAS Programmer at
2 years, 5 months at this Job
- M.SC - Information and Technology
- B.SC - Information and Technology
Johnson and Johnson has conducted several Clinical Trials and sponsored in more than 40 countries. Studies are institutional, cooperative and pharmaceutical industry trials. As a statistical programmer, I was involved in clinical trial projects that were in ETL activities. The projects primarily required developing and validating tables and analysis datasets according to CDISC, CDM and MedDRA standards and guidelines. Responsibilities: ✓ Categorized clinical trial data as per CDISC into intervention class, event class, finding class, demographic class. ✓ Used SQL procedures to replace complex merge statements. ✓ Checked SDTM compliance through OPENCDISC VALIDATOR. ✓ Converted different file formats (Excel, CSV, and Plain Text Files) to SAS datasets. ✓ SAS Import procedure/ Import wizard for non-RDMS (Excel, Access) data importing and SQL-pass through facility for importing data from RDBMS. ✓ Performed Ad-hoc Programming and Reporting. ✓ Designed flowcharts indicating the input data sets and the techniques that would be used sorting, merging, etc. to get the desired output. ✓ Generated and validated patient profiles for the different studies developed standard macros and also used existing macros according to the requirements. ✓ Prepared Efficacy analysis with tumor response (CR or PR) and survival by customized DATA_NULL programming, PROC TABULATE, PROC REPORT, FORMCHAR option for ASCII text for FDA submission. ✓ Summarized table as per mock TLG for extent of exposure, adverse event, hematology and serum toxicities, non-investigational medication, and vital sign for summary analysis. ✓ Developed TLG (table, listing, graph) and report of patient's data with descriptive and inferential statistics for continuous/categorical variables programmed by extensively using PROC FREQ, PROC UNIVARIATE, PROC MEANS, PROC LOGISTIC. ✓ Case report form Tabulation (CRT) using PROC REPORT as per CDISC SDTM standard. ✓ Developed SAS programs for summary Tables, Listing and figures, analysis datasets (CDISC ADaM) and analyses specified in the Statistical Analysis Plan. ✓ Created SAS XPORT format file as per eCTD guideline using SAS/Macro, PROC COPY, PROC CPORT ✓ 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. ✓ Formatted HTML, PDF and RTF reports, using SAS/ODS system. Environment: SAS 8/9, SAS/BASE, SAS/MACROS, SAS/STAT, SAS/ACCESS, SAS/SQL, SAS/ODS, SAS/Report, SAS/XML Mapper Oracle, Window NT/2000, Excel/Access 2000
- Sr Statistical/SAS Programmer at Johnson & Johnson
- Clinical SAS Programmer at Quanticate
- Clinical SAS Programmer at PRA Health Sciences
- SAS programmer at Novum pharmaceutical
3 years, 5 months at this Job
Converted numerous Cognos reports to SAS by taking Cognos generated SQL database code, applying advanced SAS macros, additional SAS SQL code and SAS ODS capabilities to re-produce current Cognos reports ⮚ Used the SAS Studio Velocity Template Language (VTL) to develop departmental and divisional reports which gave the users the ability to create custom reports using a Graphic User Interface ( GUI). This GUI application allowed users to run reports using pre-validated SQL database extracts, SAS code manipulation and pre-defined report filters to create reports. ⮚ Produced various ad-hoc Quality Analysis (QA) and performance reports by extraction data from a Oracle database. SAS Output Delivery System (ODS) layout and other SAS ODS report formatting tools were used along with SAS macros and SAS dataset manipulation.
- Sr. SAS Programmer III at Johnson and Johnson Vision Care
- Advanced Business Analyst at J.P Morgan - Chase Bank
- Analytic Consultant at Wells Fargo Bank
- Sr. SAS Programmer Analyst at Bank of America
1 year at this Job
- B.S. in Personnel Management - Personnel Management
• Performing the programming, quality control, testing and documentation of programs for use in creating statistical outputs (TLFs) and analysis datasets.
• Created and validated SDTM and ADaM datasets for safety and efficacy analysis.
• Generated tables as per SDTM guidelines.
• Developed analyses datasets and produced tables, listings and graphs using SAS/BASE, SAS/STATS and SAS/GRAPHS.
• Used validation tools like Open CDISC Validator to check the compliance of CDISC SDTM ready datasets and prepared reviewers guide on Open CDISC validator report to support the submissions.
• SAS MACROS were used extensively in analysis of standard clinical data and generated reports, graph, summaries and tables. Used PROC SORT, SET, updating and merging various SAS datasets.
• Analyzed and cleaned datasets using PROC FREQ, PROC MEANS and PROC UNIVARIATE.
• Performing the quality control, testing and documentation of programs for use in creating statistical outputs and analysis datasets.
• Reviewing SDTM, ADaM, TFLs and SAS programs to ensure quality of deliverables
• Performing and planning the development, implementation and validation of new process technologies, macros and applications. Analyzed existing processes and explores improvement solutions.
• Implementing programming specifications and estimate programming scope of work and assist in communicating project status. Environment: SAS/BASE, SAS/GRAPH, SAS /STAT, SAS/GRAPH, SAS /MACROS, SAS /ACCESS, SAS /ODS, SAS/SQL, R, UNIX, Windows.
- Statistical SAS programmer at AbbVie
- SAS Clinical Programmer at GCE Solutions
- Medical Coder at Accenture
- Clinical SAS programmer at Thomson Reuters
3 years at this Job
- Bachelor's in biotechnology - biotechnology
- Master of Science in Microbiology and Immunology - Microbiology and Immunology
- SAS Programmer at Cytel Statistical Software & Services Pvt. Ltd
- Clinical SAS Programmer at Bluecube IT
7 months at this Job
- MS - Pharmacy Administration
Medimmune creates new standards of care in oncology, neurology, endovascular and immunology. It is a global leader in the development, manufacturing and commercialization of novel therapies. Medimmune transforms scientific discoveries into advances in human healthcare. Its goal is to develop major commercial Drugs in respiratory, inflammation and autoimmunity related diseases. As a SAS programmer, Involved in Phase II and III clinical data analysis for ADaM/derived datasets and generated Tables, Listings and Graphs. Responsibilities:
• Worked with the Clinical Trial Data, generated reports, tables, listings and graphs using SAS in accordance with the Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs), Mock shells and departmental guidelines.
• Experience in developing Macros using SAS procedures.
• Assisted in validation, edit checks and data review listing.
• Involved in creating ADaM datasets like ADSL, ADAE, ADTTE, ADEF. Used Open CDISC Validator to validate ADaM datasets. Also created Population, Safety and Efficacy tables from the analysis datasets.
• Good experience in programming analysis datasets and generating table and listing programming for ISE (Integrated Summary of Efficacy) and ISS (Integrated Summary of Safety) submissions to the FDA.
• Provided statistical analysis of clinical trial data through SAS/STAT to the statisticians.
• Attended meetings with clinical research team along with statistician and project manager.
• Experience in working with Data management team to resolve various data issues by providing edit check programs.
• Effectively used many SAS functions like SCAN, SUBSTR, TRIM and applied strategic logic on data using INTCK, INTNX, SUM, SQRT, STD and VAR.
• Performed One-to-One merging and Match merging. Used RBREAK statements to obtain the sum of the values.
• Used PROC UNIVARIATE and SAS/STAT procedures for analyzing the data.
• Generated reports using PROC REPORT, DATA _NULL_ and PROC TABULATE for customized report writing.
• Experience in developing, validating and implementing SAS programs and produce derived datasets for analysis and generating & documenting tables, listings and graphs for clinical study reports.
• Experience with PROC SQL, PROC DATASETS, PROC FORMAT, PROC PRINT, PROC APPEND, PROC TABULATE, PROC GPLOT, PROC GCHART, PROC COMPARE, PROC IMPORT, PROC EXPORT.
• Experience with PROC TRANSPOSE, SAS/STAT procedures such as PROC FREQ, PROC MEANS.
• Experience in PROC SQL joins and PROC SQL set operators to combine tables horizontally and vertically.
• Experience in producing RTF, PDF, and HTML files using SAS ODS.
• Create SAS datasets from different external files like MS Excel, MS Access, and Tab delimited, Notepad, etc., using Import techniques like Proc Import. Environment: SAS 9.2, 9.3, 9.4, Base SAS, SAS MACROS, SAS/SQL, SAS/ACCESS, SAS/CONNECT, SAS/STAT, SAS/GRAPH, MS EXCEL, MS ACCESS, ORACLE and UNIX.
- Statistical Programmer at Medimmune
- Statistical Programmer at
- SAS Programmer at WellCare
- SAS Programmer at Novartis
1 year, 6 months at this Job