MS Office, MS Excel
Novo Nordisk, Plainsboro, NJ Feb'17-Present
Clinical SAS Programmer
Novo Nordisk is a Danish multinational pharmaceutical company headquartered in Bagsvaerd, Denmark, with production facilities in eight countries, and affiliates or offices in 75 countries.
• Responsible for providing 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 and reports according to 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.
• Modified the ADaM file specification (Variable Definition) based on Statistical Analysis Document (SAP, DPS and mockups.)
• 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.
• Participate in review process of study documents such as CRF, edit check specifications, and database design specifications written by Data Management.
• 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: SAS 9.2, Base SAS, SAS Graph, SAS Macros, SAS Report, SAS ODS, SAS Stat and Oracle Clinical
- Clinical SAS Programmer at Microsoft Tools
- Clinical SAS Programmer at Sun Pharmaceuticals
- Senior SAS Programmer at PPD Inc
2 years, 1 month at this Job
- Master's - Pharmaceutics
• PROJECT - 1:
• Phase: Phase-3 Clinical Trial.
• Category: Endocrinology. Description:
• A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Orally Administered BMS-477118 in Adults with Diabetes.
• PROJECT - 2:
• Phase: Phase-1 Clinical Trial.
• Category: Onco. Description:
• A Single-Dose, Open-Label, Randomized, Replicate Crossover Study in Adult Subjects to Assess the Bioequivalence of Drug A 560-mg Tablet Compared to Four Drug B 140-mg Capsules. Responsibilities:
➢ Understanding the study related documents such as Protocol and SAP.
➢ Generating the SDTM datasets from raw datasets as per CDISC SDTM 3.2.
➢ Implemented Standard Data Tabulation Model (SDTM), created Analysis Dataset Models (ADaM standard), and maintained System Development Life Cycle (SDLC) documentation.
➢ Created analysis datasets from SDTM datasets as per Analysis dataset spec.
➢ Generating SAP required reports by using proc report and data _null_.
➢ Used ODS in the generation of outputs in required formats like RTF, PDF and HTML etc.
➢ Perform sorting and merging techniques on the input data sets for data comparison by using PROC COMPARE to cleanse, transform, analyze and present Clinical data.
➢ Ongoing understanding of FDA regulations, Good Clinical Practice (GCP), International Conference of Harmonization (ICH), Clinical Data Interchange Standards Consortium (CDISC) and other regulatory guidelines.
➢ Fixing/Resolving the issues and providing comments upon request.
- Clinical SAS Programmer at LOTUS LABS Pvt Ltd
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2 years, 11 months at this Job
- Diploma - CLINCAL RESEARCH
• Provided programming support for Medical device trials.
• Created Adam datasets based on Adam specifications.
• Developed validated and documented programs to create Tables and Listings as per Statistical Analysis Plan (SAP) using SAS reporting procedures like Proc Report, Proc Sort, Proc Tabulate, and analysis procedures like Proc Means, and Proc Freq.
• Generated tables and listings for Adverse Events, Device Malfunction, clinical laboratory evaluations, disposition of subjects, medications and protocol violations.
• Developed and maintained automation programs that extract and run all programs (.BAT and SAS MACRO) to generate datasets and TFL.
• Worked on Ad-hoc requests for generating data listings and tables.
• Excellent programming skills in SQL and understanding of data management principles, such as joining data sets, data aggregation and sub - setting using PROC SQL.
• Written SAS macro programs to facilitate the validation of datasets.
• Interacted with Data Management colleagues to coordinate collection and reporting of clinical studies for Data Entry and Data Review.
• Performed quality review and validation of SAS programs generated by other SAS programmers.
• Followed good programming practices and adequately documented programs.
• Used SAS/Macro extensively in the creation of new programs as well as modification of existing programs to improve ease and consistency of results.
• Created analysis Tables and Listings for generating weekly Reports to the clinical team as per requirement.
• Developed programs to generate various Safety reports by referring to the Table shells and the Statistical Analysis Plan (SAP) if required.
- Clinical SAS Programmer at Insight Global
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1 year, 7 months at this Job
Company name: IQVIA Ltd
Role: Clinical Statistical SAS programmer Company IQVIA Ltd is one of the largest pharmaceutical companies with largest field force, dedicated to discovering and developing the new, and better, ways to prevent and treat disease and improve well-being of the people. Responsibilities:
• Extracted clinical data from the database following CDISC standards wrote SQL queries using PROC SQL procedures and created SAS datasets and views.
• Generated EXCEL tables for non-coded Adverse Event Terms, Concomitant Medications and Medical History Terms.
• Created edit check programs to find discrepancies in raw datasets provided by Data Management Group.
• Experienced in Base SAS procedures such as PROC FREQ, MEANS, SUMMARY, UNIVARIATE, FORMAT, IMPORT, REPORT, TABULATE, TRANSPOSE, DATASETS, COPY, PRINT and SQL.
• Provided programming support for Clinical Trial using SAS interface.
• Participated in a pilot project involved in the development of analysis data sets.
• Delivered statistical programming for Phase II study for creation of some selected safety tables and listings.
• Produced RTF and PDF formatted files using SAS/ODS to produce reports based on Client requirement.
• Performed transforming the data and analysis on the data sets using Proc Freq, Proc Means, Proc Transpose and Proc SQL.
• Performed Data management like Merging, concatenating, interleaving of SAS datasets using MERGE and SET statements in DATA step and PROC SQL.
• Good knowledge of Clinical Trials Data like Demographic Data, Adverse Events, Vitals, Laboratory Data.
• Working with Sr. programmer to complete the tasks assigned by him and learning how to work effectively.
• Generated highly customized reports using Proc Report. Company: Parexel International Ltd. Role: Clinical SAS Programmer PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of expertise-based contract research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Responsibilities:
• Expertise using SAS/BASE, SAS/MACRO, SQL, SAS/STAT, SAS/ACCESS, SAS/CONNECT, SAS/ODS, SAS/GRAPH, Excel, MS Office tools.
• Expertise in using various SAS procedures like PROC REPORT, PROC SQL, PROC FREQ, PROC MEANS, PROC TABULATE, PROC TRANSPOSE and PROC PRINT.
• Used SAS Data Step logics to Sort, Merge, Stack, Update, Array, Retain and Interleave datasets for producing required analysis of data and used SAS Business Intelligence to produce required Reports.
• Used various MACRO functions such as MPRINT, SYMBOLGEN, MLOGIC to Debug store process and SAS code
• Create different types of output files in different format like PDF, EXCEL, HTML and TEXT DELIMINATED FILE
• Created SAS analysis datasets from raw data sets.
• Transforming and deriving new variables based on the requirement for creation of TLF's based on the programming specification.
• Optimized performance using Data Validation and Data Cleaning on Clinical Trial Data.
• Performed Data analysis, generated reports, listings and graphs using SAS Tools.
• Generated Tables, Listings and Graphs using various procedures like PROC FREQ, Proc Report, Proc Tabulate PROC UNIVARIATE, Data _null_, Proc Plot, and Proc Gplot SUMMARY and provided descriptive statistics using PROC Means
• Based on the Health authority request (Ad hoc reports), produced extra repots in RTF, and HTML formatted files.
• Performed quality controls on SAS programs and documented all project data flows and programs.
• Working with CDM team, Statistician to resolve data issues and clarify the doubts when creating the analysis data sets and TLF's to get the quality reports.
• Responsible to write, modify, validate and implement SAS programs according to Statistical Analysis Plan. Company: EXL Services Ltd. Role: Senior Clinical Research Programmer At EXL, we're experts in more than analytics, operations management, and technology. Operations Management, Decision Analytics, Technology Platforms, Healthcare, Finance & Accounting, Insurance, Risk & Financial Management, Travel, Transportation and logistics, Banking and Financial Services, Operations & Process Excellence, Utilities, Analytics, Digital Intelligence, and Digital Transformation Responsibilities:
• Identification and publication of daily inpatient census
• Initiate, update and complete the Transition Process for all inpatient members
• Sending of all care plans generated by clinician staff to appropriate location
• Warm transfer of member to assigned clinician/and or customer service
• Initiate ICT log and transfer ICT recommendations to Electronic Medical Record
• Monitor turn-around times for all client performance metrics and notify Supervisor Staff of any risks to compliance
• Outreach unable to reach members for HRA completion
• Maintaining quality, productivity and procedures as defined by applicable policies and procedures
• Meeting all individual and team performance metrics, including but not limited to; call quality, average handle time, schedule adherence and attendance.
• Support all Model of Care requirements and components
- Clinical SAS Statistical Programmer at IQVIA Ltd
- Clinical SAS Programmer at Parexel International Ltd
- Senior Clinical Research Programmer at EXL Services
- at Medical Practice
10 months at this Job
- Bachelor of Homeopathic Medicine and Surgery - Homeopathic Medicine and Surgery
• Programs and documents derived datasets, listings, tables, figures and statistical appendices for mainly safety, pharmacokinetics, and pharmacodynamic endpoints on studies of low complexity.
• Ensuring that all programming activities are executed in a timely manner and to the required high statistical and reporting standards as specified in Standard Operating Procedures (SOPs)
• ensures that the deliveries match the agreed specifications. Supports quality control and quality audits of deliverables.
• If required, prepares datasets for electronic submission to regulatory authorities in line with applicable guidelines and requirements.
• Worked on analysis data sets (ADAM) to reflect the specifications, ADAM implementation guide and the Statistical Analysis Plan (SAP).
• Created project specific MACROS, TEMPLATE and FORMAT catalogue.
• Involved in creating project specific datasets and tables for interim analysis.
• Developed TABLES, LISTINGS and GRAPHS for various studies as per the Statistical Analysis Plan (SAP).
• Used PROC REPORT and SAS/ODS feature to create the TABLES and LISTINGS
• Involved with the Validation of SDTM datasets, ADAM datasets, TABLES and LISTINGS
• Extensive experience in creating LABORATORY tables (Summary, Shift of Lab values, Shift Categorization).
• Created standard macros and applications to improve the efficiency of the department.
• Involved in various projects and was an active team member in project meetings interacting with Biostatisticians, Team leaders and project managers to analyze the data and to discuss the status of the project
- Clinical SAS Programmer at Medline health care
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- Clinical SAS Analyst at Icon International Pvt. Ltd., HYD
2 years, 7 months at this Job
• Experienced clinical SAS Programmer with over 5+years of statistical programming and data analysis experience in Pharmaceutical industry.
• Worked on Phase I to III of Clinical Trials.
• Experienced with CDISCSDTM (IG3.1.2, 3.1.3 and 3.2) and ADaM (IG 1.0) standards.
• Created safety, and efficacy SDTM and ADaM datasets, summary tables, listings and graphs (TLFs).
• Proficient at using SAS datastep and procedures.
• Experienced in generating Integrated Summaries of Safety and Efficacy (ISS, ISE).
• Validated Analysis datasets and TLFs using parallel programming and other validation techniques.
• Created new macros and modified existing macros based on the departmental and study level requirements.
• Experienced in writing SDTM mapping and ADaM specifications.
• Experience in various therapeutic areas including oncology.
• Performed incidence rate, survival and statistical analysis using proc lifetest and proc phreg.
• Supported NDA submissions by reviewing define.xml, creating xpt files.
• Programmed Edit Check programs to create reports for data cleaning and data validation.
• Interacted with other departments such as Bio-Statistics, Data Management, Medical Writers etc.
• Experienced in reviewing Protocol, SAP, Dataset specification and mock shells.
• Excellent communication skills.
- Sr. SAS Programmer at CLIN CRO SERVICES
1 year, 10 months at this Job
- M.S - Computer science
- Bachelor of Pharmacy - Pharmacy
• Developing on data integration with statisticians and data management staff for efficacy and safety of drugs in trials.
• Working on integration and validation of datasets from multiple studies as per programs requirement and specifications.
• Preparing SDTM datasets and analysis reports following the ADaM format for integrated summary of safety and effectiveness.
• Developing high quality customized tables, reports and listings using PROC TABULATE, PROC SUMMARY and PROC REPORT.
• Providing descriptive statistical analysis using tools like PROC FREQUENCY, PROC MEANS and PROC UNIVARIATE.
• Using tools such as SAS/Access and SAS/SQL to create and extract oracle tables.
• Developing and generating regression, correlation studies and analysis of variance and programmed mapping of new datasets.
• Creating SAS reports of clinical trial results by using Data _Null_ procedures and Proc Report for submissions to FDA as per user requests.
• Environment: Base SAS and SAS Macros, Access, Stat, SQL, ODS, and Graph, MS-Excel, MS-Access.
- SAS Programmer at Gilead Sciences
- Clinical Statistical Programmer at Icon Clinical Research
- Clinical SAS Programmer at QuatRx Pharmaceuticals
- SAS Programmer at Spaulding Clinical Research
5 years, 1 month at this Job
- Master's - Biomedical science & Engineering
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
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- Clinical SAS Programmer at PRA Health Sciences
- SAS programmer at Novum pharmaceutical
3 years at this Job
• Developed programs for Phase I and II clinical trials to create SAS datasets and analyzed Phase II.
• Worked as a part of E-Submission team and contributed towards the Data Cleaning and Data validation of the analysis datasets as per the CDISC standards.
• Reviewed and provided feedback on case report form designs, CRF annotations, edit checks and SAP.
• Used programming tools such as SAS Base (Windows and Unix), SAS MACRO, PROC SQL, Microsoft Excel, etc to develop the application/programs as per the specifications.
• Generated reports using Proc FREQ, MEANS, TABULATE and REPORT.
• Incorporated MedDRA terms in the existing Adverse Event data by creating a mapping Macro.
• Used SAS ODS for generating reports in specific output formats like RTF, PDF, and HTML.
• Created CRT's (Case Report Tabulations) using CDISC standards for submissions to the FDA.
• Created SAS reports using Proc Report as per FDA regulations.
• Successfully validated TLG's through independent validation using Proc compare and departmental macros.
• Extracted data from different sources and converted the data into SAS data sets using Proc Sort, Proc
• SQL procedures. Developed macros to map the datasets using CDISC standards.
• Extracted, validated and generated SAS data sets from Oracle using 'SQL Pass through Facility'.
• Worked on SAS/GRAPH to present results in BAR CHARTS, PIE CHARTS and SCATTER PLOTS.
• Used SAS Macros in creation of new programs as well as modification of existing programs.
• Written programs for checking the metadata quality based on the company provided guidelines.
• Knowledge in Medidata Rave and worked on eCRF development activities. Environment: SAS 9.2, SAS/BASE, SAS/MACROS, SAS/SQL, Oracle Clinical, Medidata RAVE.
- SAS Programmer at Novartis - NJ
- Clinical SAS Programmer at Novartis - NJ
- Database analyst at Novartis Healthcare, IN
- ECRF Developer-II at Novartis Healthcare, IN
3 years, 6 months at this Job
- Master of Technology - Technology
Theorem Clinical Research specializes in designing customized solutions to aid the pharmaceutical, biotechnology, medical devices and diagnostics industry by establishing the safety, efficacy and value of health technologies. Primary areas of research include registries and late-phase clinical trial studies as well as market research and strategies.
Therapeutic area: Oncology/Hematology
• Provided SAS Programming and analysis support for phase III (oncology) clinical trials
• Co-worked with Statisticians as a primary SAS programmer to analyze initial data sets and create tables, listings and figures (TLFs) for clinical trials.
• Created tables, graph to generate clinical study reports for the collected requirement from the statisticians referring to the Statistical Analysis Plan (SAP).
• Used procedures like PROC TRANSPOSE, PROC SORT, etc in Data transformation and Manipulation processes.
• Extensively used Proc SQL, Proc Transpose, Proc Format, Proc Means, Proc Univariate, Proc Freq, Proc Printto and Proc Compare for checking the assumptions and conducting Statistical Analysis.
• Produced Ad hoc reports of various kinds like Listings, Tables, and Figures (TLGs/TLFs) using Proc Report, Proc Tabulate, Data _Null_ technique, Proc Gplot etc.
• Used SAS ODS to report outputs in different formats like RTF, PDF, and HTML
• SAS macros were successfully used to create new programs and modified existing SAS programs to make them portable as well as for consistency of results.
• Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.
• Majorly worked with the data management team and was involved in handling documentation and submission processes (under managers' assistance). Environment: Windows 2008, Oracle 10g, SASV9.1.3, Base/SAS, SAS/Access, SAS/Macro, SAS/STAT
- Clinical SAS programmer at Theorem Clinical Research
- Jr. Statistical programmer at Gratisol Labs Limited
3 years, 10 months at this Job
- Master of Pharmacy - Pharmacy
- Bachelor of Pharmacy - Pharmacy