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Click here or scroll down to respond to this candidateCandidate's Name
Lead/Sr Statistical ProgrammerE-mail : EMAIL AVAILABLEPhone : PHONE NUMBER AVAILABLESUMMARY:Overall, 11+ years of SAS programming experience in the Pharmaceutical and CRO industries.Extensively worked on Data mapping from Existing Raw data to CDISC SDTM Standard domains and reviewed CRFs (Case Report Forms) to ensure consistency with protocol and adequacy in collecting data to meet objectives defined in the protocol.Extensive experience working with various SAS Modules like SAS/Base, SAS/Macros, SAS/SQL, SAS/Graph, SAS/Stat, SAS/ODS, SAS/Access, and SAS Enterprise Guide.Expertise in SAS Programming with a statistical background in phases I, II, and III of clinical trials.Extensive experience in generating SDTM datasets for Special Purpose Domains, Events, and Findings Domains from raw data sets by following CRF, Dataset Specifications, ADAM, and CDISCSDTM standards.Expert in using SAS/ODS to create Ad-hoc RTF, HTML, PDF, and Listing output reports.Extensively used various SAS procedures like Proc Transpose, Proc Univariate, Proc Summary, Proc Means, Proc Freq, Proc Tabulate, Proc Contents, Proc Sort, Proc Print, Proc Glm, Proc SQL, Proc GPLOT, and Proc GCHART.Involved in the process of generating Tables/Listings for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA Submission.Mentoring and Training the Team as per the Study requirement.Creating QC Checklist for QA audits and attending the QA Audits before Study Submissions.Attended the Study Meetings with Sponsors and discussed studies related to required documents and timelines.Experience in implementing corporate quality standards, ICH-GCP, FDA, and other international regulatory requirements to upgrade/change system-based applications.Review and provide inputs for essential trial documents such as protocol, CRF, Data management plan (DMP), and statistical analysis plan (SAP).Clearing Pinnacle 21 errors and Warnings.Worked on therapeutic areas like Oncology, Central Nervous System, Vaccines, Respiratory, Cardiovascular, COVID-19, Dermatology, and Autoimmune Disease.Worked with different clinical trial data like Demographics (DM), Adverse Events (AE), Serious Adverse Events (SAE), Laboratory-chemistry/Hematology/Urine analysis, and Vital signs.Proficient in Quality Control/Validation of analysis datasets according to SOP standards.Expert in the creation of Define.XML for SDTM and ADaM.Expert in Define BIMO FDAs Bioresearch Monitoring ProgramUse efficient programming techniques to produce derived datasets.(e.g., SDTM, ADaM), tables and data listings of any complexity.Involved in all CDISC projects, developed ADaM datasets as per specification andreferred protocol, SAP, and CRF.Possess extensive knowledge in understanding Protocol, Case Report Forms (CRF),Statistical Analysis Plan (SAP) and developing SDTM/ADaM datasets using Specs.provided by statisticians and mentioned the CDISC-SDTM/ADaM Guideline rules.Experience in Data Manipulation procedures such as SAS Formats/Informatics, Merge, Proc Datasets, Proc Sort, and Proc TransposeProficient in using basic UNIX commands and experienced in working on both UNIX and Windows versions of SAS.Knowledge of CRF-Annotation used various database designs.Experience in Python and R Programming in the Production of Analysis, Tabulations, Listings, and Graphs from Clinical Trial Data.Making efficient usage of SAS functions and Procedures, including common statistical procedures.Expertise in analyzing and coordinating clinical data, generating detailed and summary reports, and SQL-Data Validation using FDA Regulation procedures.Excellent team player with the ability to work individually as well as in teams.Highly motivated and consistently meeting Aggressive Deadlines.Strong communication, interpersonal, analytical, leadership, and problem-solving skills.TECHNICAL EXPERTISESAS ToolsSAS 8.2/9.1.3, SAS/BASE, SAS/STAT, SAS/MACRO, SAS/SQL, SAS/ACCESS, SAS/GRAPH, SAS/ODS, SAS/CONNECTOperating SystemsWindows 98-2003, 2007/NT/XP/VISTA, UNIXLanguagesSQL, UNIX, C++, R, PythonDatabase ManagementORACLE Inform, SQL Server, Microsoft Access, Argus Safety, ArisGOffice SoftwareMS Office (Word, PowerPoint, Excel, Access)PROFESSIONAL EXPERIENCE:Company: Symbiance Pharma Solutions Pvt Ltd Dec 2021 - Dec 2022Client: Parexel, NCRole: Lead/ Sr Statistical ProgrammerResponsibilities:Developed programs that convert raw SAS datasets into standard format and improve existing programs by creating standard programs and macros.Mapped raw data to SDTM in compliance with CDISC data model standards as per the SDTM specification document.Independently programmed CDSIC SDTM and ADaM datasets.Validated SDTM domains using the SAS compare procedure and Pinnacle 21 tool.Independently developed QC programs to validate peer programmers' SDTM domains, ADaM datasets, statistical tables, and listings.Worked on the Oncology therapeutic area and creation of CDISC data sets.Worked with Managers, and Statisticians to create analysis datasets to generate safety and Efficacy reports for the various studies.Mentoring and Training the Team as per the Study requirement.Generated Safety and Efficacy tables, and listings as per the requirement to support publications, data safety monitoring committee (DSMB) submissions, clinical study reports, and ad-hoc statistical analysis.Participated in ISS and ISE programming activities, provided programming support, and reviewed submission-ready documents.Reviewed Define.xml, analyzed data reviewers guide, and converted the format files to XPT format files using Proc Copy and EXPORT engine.Written Edit checks to verify the data issues and implemented SAS edit check templates.Worked on generating the ADaM datasets as per the analysis needs based on the ADaM specification file.Provided SAS programming support to generate Safety reports such as a summary of adverse events, lab data summaries by visit and shift tables, abnormal vital signs summaries, and Efficacy tables not limited to progression-free survival, disease response summaries, and overall survival summaries.Worked on efficacy datasets like RECIST and programmed customized data displays.Worked on efficacy tables and listings like a summary of best overall response, duration of overall response, and progression-free survival analysis by Kaplan Meier method, waterfall plot for best percentage change from baseline in the sum of longest diameter.Worked on mixed model effect tables.Having good knowledge of concepts like censoring events, Time to event, progression-free survival, DCR, and best overall response.Worked on figures like scattered plots, box plots, semi-log plots, waterfall plots, KM Plots, etc..Prepared codes with the help of SAS PROCEDURES such as REPORT, SQL, FORMAT, MEANS, UNIVARIATE, and FREQ, to generate output in the desired report formats.Prepared safety listings related to DM, AE, MH, CM, EX, VS domains.Prepared tables like the summary of demographics, a summary of baseline characteristics, a summary of disposition, related to DM,Worked on toxicity grade tables, DLT tables, a summary of TEAE, etc. related to AE.Worked on shift tables, and criterion tables related to LB, VS, and EG.Worked on outputs related to AE, MH, CM, EX, VS, LB, PK parameters, etc.Client: Novartis, NJ Apr 2021 Nov 2021Company: Ecron Acunova LimitedRole: Sr Statistical ProgrammerResponsibilitiesSuccessfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis.Developed programs to prepare the safety and efficacy tables, listings, and graphs (TLG) required for the Clinical Trial Report (CTR) and the associated Analysis Data Sets.Generated various kinds of reports like Listings, Tables, and Figures (TLGs/TLFs), and ad-hoc reports using Proc report, Proc GPLOT, etc.Reviewed key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements.Mentoring and Training the Team as per the Study requirement.Creating Define BIMO Bioresearch Monitoring.Created CDISC SDTM and ADaM datasets.Analyzed raw data and provided input to Statisticians regarding analysis dataset specifications.Develop SAS macros for use in clinical studies.Mentoring and Training.Creating QC Checklist for QA audits.Study meetings with Sponsors.Writing project-specific macros and initial study folder creation, will be useful to understand the hierarchy of study.Responsible for the proper coding, documentation, and validation of SAS programs/macros/procedures to produce the standardized data display.Performed verification of SAS-generated outputs (Table, Listings, and Graphs) via independent programming.Established and maintained libraries of fully documented and validated SAS programs/macros/procedures that were used.Ensured proper and consistent implementation and maintenance of guidelines and standards within the department.Clearing Pinnacle 21 errors and Warnings.Involved in activities of developing XPTs to run pinnacle and adding comments.Involved in activities of developing GMF and clearing log warnings and errors.Involved in the generation of SDTM and ADaM Reviewers Guide.Performed data checks before database lock for the data management team.Generated ad-hoc tables, listings using SAS/ODS and proficient in ODS RTFPrepared TLGs and statistical outputs for analysis as per shells.Attends QA internal and External Audits to Explain Project Complete details.Generated Patient Profiles as per the requirement at the study level for special attention AEs.Created datasets like Demographics (DM), exposure (EX), concomitant/prior medications (CM), adverse event (AE), disposition (DS), medical history (MH), Vital signs (VS), ECG (EG) Trial domains etc in SDTM Plus standards.Created other study specific datasets such as antineoplastic medications, antineoplastic surgeries, antineoplastic radiation, last alive data, tumor response, tumor identification etc.Worked on ADAM datasets such as ADSL, ADAE, ADCM, ADEG, ADDV, ADVS, ADLB, ADEX, PK-merge, RECIST, ADQS, ADQLQ, ADEQ5D5L, ADTR, ADRS, ADEVENT, ADAETTE and ADTTEInvolved in sorting, printing and summarizing the SAS Data, modifying and combining SAS datasets.Worked on pooled studies.Company: Navitas Life Sciences Feb 2019 Mar 2021Client: Novartis, NJRole: Sr Statistical ProgrammerResponsibilitiesSuccessfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis.Developed programs to prepare the safety and efficacy tables, listings, and graphs (TLG) required for the Clinical Trial Report (CTR) and the associated Analysis Data Sets.Generated various kinds of reports like Listings, Tables, and Figures (TLGs/TLFs), and ad-hoc reports using Proc report, Proc GPLOT, etc.Reviewed key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements.Mentoring and Training the Team as per the Study requirement.Creating Define BIMO Bioresearch Monitoring.Created CDISC SDTM and ADaM datasets.Analyzed raw data and provided input to Statisticians regarding analysis dataset specifications.Develop SAS macros for use in clinical studies.Mentoring and Training.Creating QC Checklist for QA audits.Study meetings with Sponsors.Writing project-specific macros and initial study folder creation, will be useful to understand the hierarchy of study.Responsible for the proper coding, documentation, and validation of SAS programs/macros/procedures to produce the standardized data display.Performed verification of SAS-generated outputs (Table, Listings, and Graphs) via independent programming.Established and maintained libraries of fully documented and validated SAS programs/macros/procedures that were used.Ensured proper and consistent implementation and maintenance of guidelines and standards within the department.Clearing Pinnacle 21 errors and Warnings.Involved in activities of developing XPTs to run pinnacle and adding comments.Involved in activities of developing GMF and clearing log warnings and errors.Involved in the generation of SDTM and ADaM Reviewers Guide.Performed data checks before database lock for the data management team.Generated ad-hoc tables, listings using SAS/ODS and proficient in ODS RTFCompany: Icon Clinical Research June 2017 Jan 2019Client: Novartis, NJRole: Sr. SAS ProgrammerResponsibilities:Responsible for preparing study-level specs for the dataset using CDISC STDM standards.Mapped and standardized raw datasets for legacy datasets according to the CDISC SDTM Model.Developed programs to generate analysis datasets (created ISO date character variables).Performed CRF SDTM annotations and CDISC Controlled Terminology Management.Mentoring and Training the Team as per the Study requirement.Update standard macros based on raw data and mapped complex data as per the guidelines provided.Reviewed and commented on Protocol, Annotated Case Report Form (CRF), Controlled Terminology, and raw datasets for all studies assigned.Involved in the creation of analysis data sets, tables, listings, and figures.Developed and validated Oncology-Specific domains of Tumor Identification (TU), Tumor Results (TR), and Disease Response (RS) and their respective ADaM domains.Extensive Knowledge of electronic submission standardsProgram development in support of CSR and ADHOC requests from Clinical with emphasis on meeting regulatory requirements for TLFs, uniformity, and program compatibility.Generated Listings and reports for presenting the findings of various statistical procedures using procedures like PROC REPORT, PROC FREQ, PROC LIFETEST, PROC MIXED, and SAS ODS.Used SAS ODS facility to create HTML, RTF, and PDF output files in the process of creating reports.Extensively involved in peer validation of SAS programs and programmed edit checks to report inconsistencies and discrepancies in the database.Pulling the study-specific raw data sets from the Rave database for data cleaning and report generation.Writing project-specific macros and initial study folder setup, which will be useful to understand the hierarchy of study.Programming of Self-Check Listings for data cleaning and sending the issues to Data Operations Co-Ordinators.Performed Data Validation and Data cleaning by Peer-Reviewing.Wrote Quality Control programs for various reporting stages and generated analysis datasets, Tables, Listings, and Graphs.Performed validation activities to ensure the quality of the electronic submission and contributed towards creating Tables and listings and validating the analysis datasets as per the Data Specifications.Performed ad hoc programming as per clients requests.Company: United Health Group, India Jan 2012 June 2017Role: Statistical ProgrammerResponsibilities:Extensive experience in CDISC SDTM with Med DRA dictionary coding/decoding skills and mapped the SAS data into SDTM which helped in the Feasibility of Electronic Submissions.Supported non-technical users to prepare CRF and SAP according to the protocol requirements.Involved in reviewing the study protocol and case report form (CRF) and performing validation of clinical trial data to identify the error entries.Mentoring and Training the Team as per the Study requirement.Supported Industry standards for design by the Clinical Data Interchange Standards Consortium (CDISC)Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis. Supported programming activity for Clinical trials of Dermatology and Hematology.Involved in creating SAS Programs for the validation of tables in drug studies.Successfully validated TLGs using validation techniques using various procedures and macros.Generated reports in compliance with 21 Code of Federal Regulations (21CFR) part I, FDA, data transmission and integrity check for the Clinical trial systemsDeveloping SDTM Domains based on SDTM IG 3.1.2 and 3.2.Excellent team player with the ability to work individually as well as in teams.Generating reports by using procedures like Proc Sort, Proc Means, and Proc Report.Data step programming with SAS functions mainly INPUT, PUT, SUBSTR, INDEX, SCAN, SET, MERGE, and BY group processing for data manipulations.Created various reports in Excel and HTML format for customers using statistical procedures PROC SQL, PROC REPORT, PROC SUMMARY, and PROC GCHART and preset MACROS as per requirement.Thorough Knowledge in reviewing source data and annotated Case Report Forms; developing, reviewing, and/or utilizing database mapping specifications used to produce analysis datasets from source datasets; and implementing programs to accomplish the mapping outlined by these specifications.Contributed to weekly group status meetings and occasionally helped in information sessions for new hires.Review and streamline outdated SAS code to eliminate errors and improve functionality.Modified the existing SAS datasets using the set, merge, sort, and update functions.EDUCATION QUALIFICATION:Masters in Management Information Systems (MSMIS), AUBURN UNIVERSITY AT MONTGOMERY, Alabama AL.Bachelor of Science B Pharmacy, PRRM College of Pharmacy. 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