• Provided SAS programming and analysis support for several studies in close collaboration with Statisticians.
• Develop analysis datasets and generate tables, listings, and graphs as per SAP.
• Design/develop SAS macros and other utilities to expedite SAS programming activities.
• Participate in statistical program validation and quality control activities.
• Develop SDTM mapping documents, complete programming and validation of CDISC SDTM and ADaM datasets.
• Created SAS listings and tables in PDF, RTF formats using SAS ODS.
• Used various procedures like PROC FREQ, PROC MEANS, PROC TABULATE, PROC SUMMARY and PROC REPORT to generate various data tables, patient data listings & reports as per Statistical Analysis Plan (SAP)
• Reviewed CRF's to ensure consistency with protocol and adequacy to collect the data to meet the objectives defined in the statistical section of the protocol.
• Assisting Senior Programmer in generating Tables, Listings and Graphs.
• Using SAS/GRAPH Procedures like Proc gchart and Proc gplot.
• Attending several meetings with Senior Programmer and Statistician.
• Used the SAS Macro facility to produce weekly and monthly reports.
• Using SAS/Base, SAS/SQL procedures and provided programming expertise for employees and sponsors as needed.
• Modified ADaM file specification based on Statistical Analysis Document (SAP, DPS & mockups.)
• Developed Analysis datasets for Safety and Efficacy data. (Demographics, LAB, Adverse Events, Medical History, Physical Examination, ECG, Concomitant Medications, Overall Pain, Vital Signs, and Concomitant Medication) as per Statistical Analysis Plan (SAP).
• Interact with other departments such as Clinical Operations, Project Management, and Data management to ensure a high level of client satisfaction through successful execution of projects.
• Responsible for ensuring consistencies in database structures, programming edit checks and data listings, performing validations of programs and participating in database locking activities.
• Reviewed data from clinical trials and developed plans to presenting results to FDA. Environment: PC SAS, Base SAS, SAS Graph, SAS Macros, SAS Report, SAS ODS, SAS Stat and Oracle Clinical
- Senior Clinical SAS Programmer at SCAN Health Plan
- Senior Clinical SAS Programmer at Blue Cross Blue Shield
- Clinical SAS Programmer at Vertex Pharmaceuticals
- Clinical SAS Programmer at Celgene
8 months at this Job
- - Object Oriented Analysis and Design
• Performed Programming, testing and validating programs for use in creating analysis files
• Created SDTM data sets and tables as per CDISC guidelines
• Generated Reports based on demographics (DM) for a drug study involving subjects of various ages, race and ethnicity
• Used various SAS sorting and merging Procedures like PROC SORT, PROC SORT and PROC MERGE
• Created RTF, PDF and HTML reports using SAS/ODS
• Extensively used PROC GPLOT and PROC GCHART for generating graphs and plots
• Reviewed the Statistical Analysis Plan in preparation for programming the planned analyses.
• Generated tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request.
• Efficiently designed macros for code reusability in Creating and Analysis of data sets
• Participated in statistical program validation and quality control activities.
• Actively participated in study team meetings.
• Interacted with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects.
• Participated in review process of study documents such as the CRF, edit check specifications, and database design specifications written by Data Management.
• Performed data cleaning checks, as necessary, to assist Data Management's data cleaning activities.
• Developed and maintained the infrastructure for project files of SAS datasets and SAS code.
• Team member and involved in overseeing the team while performing all aspects of SAS programming required for clinical trial analysis and reporting.
• Ensured all programming activities and processes performed are conducted according to Organization standard procedures and/or sponsor requirements.
• Adhered to all aspects of the Organization quality system.
• Complied with Organization data integrity & business ethics requirements.
• Performed other related duties incidental to the work described herein. Environment: SAS 9.3, Windows, SAS/BASE, SAS GRAPH, SAS ODS, SAS STAT, MACROS, MS- Excel, MS-Access.
- Clinical SAS Programmer at Parexel International
- SAS Programmer at Citrus International, Inc
- Clinical SAS Programmer at AstraZeneca
- SAS Programmer at AXIS Clinical Limited
5 months at this Job
- BACHELOR OF SCIENCE - MICRO BIOLOGY
- MASTER OF SCIENCE - ENVIRONMENTAL Science
- Sr Clinical SAS Programmer/Analyst at PPD Development
- SAS Developer at HDMS
6 years at this Job
- Master's - BioTechnology
• Involved in developing new or modified SAS programs to load data and to use them for report generation.
• Created datasets from raw datafiles using Import procedure and modified existing datasets using Set, Merge, Sort, Formats and conditional statements.
• Developed programs to create tables, listings and figures as per requirement. Outputs were produced as per client requirement in desired formats using ODS.
• Worked on AD-Hoc requirements on ADaM, Tables, Listings.
• Reviewed draft and production programs before deliverable to ensure quality and consistency.
• Trained on creating and implementing Macros where ever necessary.
• Regular attendance to meetings under senior programmers, Biostatisticians to discuss the project status and any other issues when needed.
• Efficient usage of Proc SQL in programming for example-calculation BigN's in tables mostly, and calculate counts and used where ever necessary. Studies: Cardiovascular, Breast Cancer (Oncology), Gastritis, Peanut Allergy, Perennial keratoconjunctivitis
- Clinical SAS Programmer at Etera Solutions LLC
- SAS Programmer at Sun Pharmaceuticals
1 year, 11 months at this Job
- Masters in Information Technology - Health Care Informatics
- Bachelors in Pharmacy - Pharmacy
Under the supervision of a Sr. Clinical Database Programmer and the Manager, Clinical Database Programming, the Database Programmer is responsible for producing standard and custom reports for use by the Clinical Data Managers in their data review and cleaning efforts, developing transfer specifications with vendors for external data sources, performing Study Data Tabulation Model (SDTM) conversion programming and Quality Control (QC) and handling all other ad-hoc data requests by project team members for assigned studies.
• Extract clinical data from the clinical data management system and produce standard and custom reports, primarily in SAS
• Program reports and listings as requested by project team members for ongoing studies
• Develop transfer specifications with vendors for external data sources
• Perform consistency checks on data transferred between Incyte and external parties to ensure completeness and accuracy of data contained transfers
• Perform programming to convert raw, clinical trial data to Study Data Tabulation Model (SDTM) format
• Perform Quality Control (QC) on programming work performed by fellow Database Programmers
• Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency
• Other duties, as assigned.
- Clinical SAS Programmer at Incyte Corp
- SAS Data Programmer - Assignment to Incyte at Remx IT
- Clinical SAS Programmer at Hudson IT
- Sr. Clinical SAS Programmer at AstraZeneca
6 years, 6 months at this Job
- B.S. in Information Technology - Information Technology
• Prepared/reviewed protocol documents, case report forms, annotated CRF, and statistical analysis plans for clinical trials.
• Developed SAS Programs for different type Phases of clinical trials.
• Knowledge of CRF Annotation by automated and manual mapping.
• Developed and analyzed Datasets according to client standards.
• Strong emphasis in Clinical Trials and thorough knowledge of Phase I-IV Clinical trials
• Strong ADaM Implementation experience and creation of ADaM data specifications and data definition tables in Phases 1-4 of clinical-trials.
• Experience in Mapping raw and analysis in compliance with CDISC standards using SDTM (v 3.1.2), ADAM (v 1.0) and Define.xml models.
• Base SAS, SAS Macros, SAS/SQL, SAS/ Graph, SAS/STAT and various SAS procedure
• Statistical Programming technical leadership and supported to team members.
• Performed Statistical data analysis according to the FDA technical conformance guide
• Constructed estimates of project resource requirements and time lines and routinely briefing management on accomplishments, status of projects, and any issues.
• Effectively designed and coded SAS programs for assigned project(s), consistently meeting objectives of the project
• Coded complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic submissions of data in CDlSC format with minimal instruction or input from supervisor
• Provided guidance on the resolution of highly complex clinical trial reporting problems within budget and time line constraints, while assuring high quality standards
• Performs quality control checks of advanced SAS code and output produced by other Statistical Programmers
• Responsible for maintaining excellent working knowledge of medical data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry
• conducted briefings and participated in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMEA, et cetera), on assigned projects
• Managed project timelines and schedules of specific phases of projects and contracts with internal personnel and outside customer representatives.
• Provided data review and data visualization for clinical trials Program analysis datasets, tables, listings, and figures across several trials Develop and comply with project/study programming standards and specifications following internal guidelines Support quality control and quality audit of deliverables Skills using tools like JMP and JReview
• Designed and developed SAS macros, applications, and other tools to expedite SAS programming activities to support different areas of Clinical data review.
• Designed standard programs and macros using study metadata to analyze data according to TRC rejection criteria
• Good understanding of Regulatory requirements for Clinical and non- clinical study data submissions to FDA
- Clinical SAS Programmer/ Sr Statistical Programmer at Agisol
- Clinical SAS Programmer at Orision
9 months at this Job
- Clinical SAS Programmer at
- Jr. Clinical SAS programmer at TATA CONSULTANCY SERVICES
- Clinical SAS Programmer at Sanjeevani Bio Services Pvt Ltd
1 year, 1 month at this Job
- - M Pharmacy
* Extensive experience with SAS programming, various SAS Procedures in Base SAS and thorough knowledge of SAS Macros.
* Successfully created Tables, Listings and Graphs using various procedures.
• Analyzed Phase ΙΙ and ΙΙΙ Clinical Trials through SAS programming and by providing statistical support to Statisticians and Biostatisticians.
• Wrote Edit Check programs using PL/SQL for Data validation before using for final analysis.
• Involved in writing the SAS codes to help in the process of Quality control by implementing various statistical procedures like FREQ, MEANS, TRANSPOSE, SQL and PRINT.
• Optimized performance using Data Validation and Data Cleaning on Clinical Trial Data.
• Created SAS Macros and modified the existing ones relating to multiple studies.
• Effectively and timely contacted Project Manager of the respective study about the various Data Issues and resolved the queries through meetings.
• Maintained appropriate study application documentation.
• Performed Program Documentation on all programs, files and variables for accurate historical record and for future reference.
• Successfully validated study TLG's and CRT's through independent validation using proc compare and departmental standard macros.
• Proficient in indicating the input data sets, setting, sorting and merging techniques to get the required report.
• Produced Tables, Listings and Graphs for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Involved in creating the datasets and statistical summaries/analysis using Analysis Datasets (ADaM).
• Created CRT's (Case Report Tabulations) and listing reports using SDTM and ADaM datasets.
• Experience in handling multi projects efficiently.
• Generated ad-hoc reports and browser viewable reports using SAS/ODS.
• Successfully handled Windows and UNIX environment.
• Produced RTF, MS WORD and HTML formatted files using SAS/ODS to produce ad hoc reports for presentation and further analysis.
- Senior Lead SAS Programmer/Clinical SAS Engineer at Bank of New York
- Senior Clinical SAS Developer/Lead at ABL
- Senior SAS Programmer/Clinical SAS Analyst at GlaxoSmithKline
- Clinical SAS Analyst/ SAS Programmer at American Express
3 years, 3 months at this Job
• 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.
• Solid data analysis programming skills using SAS and R
• 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
2 years, 10 months at this Job
- Bachelor's - biotechnology
- Master of Science - Microbiology and Immunology
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, 3 months at this Job