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Click here or scroll down to respond to this candidateSreenivas Velamakanni Email: EMAIL AVAILABLEMobile: PHONE NUMBER AVAILABLESAFe 4 Certified PractitionerSummary:12+ years of SAS programming experience with Clinical trials data on different phases (Phase 1-IV).Worked on different clinical phases including discovery, pre-clinical and clinical trials.Experience working with the Bio-statistics and the Clinical Data Management Programming teams.Experience with various therapeutic areas (TAs) like Oncology, CVS, RA, Metabolic, Pulmonary, CNS and GI.Familiarity with clinical databases like Oracle Clinical, Rave, Inform etc.;Develop, programming, testing and maintaining computer validation/edit checks in Medidata Rave and/or Oracle Clinical or Inform.Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.Knowledge of CDISC standards, Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) supporting clinical trials for regulatory submissions.Demonstrated ability in handling and processing upstream data, e.g., multiple data forms, workflow, eDC, CDISC SDTM and ADaM formats.Contribute to the creation of naming conventions and standards CT (Controlled Terminology) for the CDISC environment.Good knowledge of pharmaceutical terminology, clinical trials data structure, statistical analysis and protocol designs.Integrating data from different sources (SAS datasets, CRF data and electronic laboratory data).Experience with cleaning and resolving data issues and performing data analysis.Performing Cleaning Techniques, QC Validation and Edit Checks as per protocol designs on Clinical Data.Used Data migration procedures for importing and exporting data from Excel spreadsheets, CSV, Tab DLM and any DLM to SAS datasets.Programming experience in SAS using Base SAS, Macros, Proc SQL, and SAS/STAT in UNIX and Windows environments.Generating reports with various formats like the RTF, CSV, PDF and XML formats.Also possess 2 years experience working with Watson LIMS (Bio-Analytical) and SAP CPCC applications.Familiarity with the SDLC methodology and Post-Marketing or Prescription Data (IMS/NDC) analysis in a pharmaceutical setting.Proficient in Application Development skills in more than one technology and multiple design techniques.Experience with Business System Analysis including in depth knowledge of Software Development Life Cycle (SDLC) and practical knowledge of development methodologies like Agile SCRUM, RUP and Waterfall.Experience with both traditional Waterfall SDLC and Agile/Lean methodologies in an Agile/Scrum/XP environment.SAFe 4 Certified Practitioner and a certified SFC (Scrum Fundamentals Certification).Employment Details:Orbis Clinical/Zymeworks Jun21 CurrentRaleigh, NCJob Title: Senior Statistical Programmer (SAS)Location: Remote/Raleigh, NCResponsibilities:Good experience with CDISC Standards and currently working, as a Senior Statistical Programmer..Experience working with SDTM conversions, ADaM (ADSL, BDS, OCCDS) data structures, and creating Define.xml, Reviewers Guides.Utilized the specific standard SAS macros, templates, MDR (metadata repository) and programming standards within the biometrics department.Involved in developing, debugging, and validating project-specific SAS programs for generating derived SAS datasets, summary tables, and data listings according to the organizational standards.Developed SAS programs to generate analysis outputs as specified in the statistical analysis plan and mock up table shells.Providing support using Pinnacle 21 (Enterprise) for developing and validating SDTM and ADaM artifacts towards e-submission.Involved in preparing the necessary documents (Define.xml, Reviewers Guide, datasets in xpt format) required for regulatory submission (NDA).Develop and maintain CDISC compliant SDTM and ADaM data set specifications for clinical studies.Developing and executing program codes in production and testing environments for all ongoing clinical studies periodically, either in an interactive session and/or in a remote session (batch mode).Performing analysis and validation of ADaM datasets and TLFs (Tables, Listings & Figures).Possess good Oncology experience in Solid Tumor, and familiarity with RECIST 1.1 and programming of Response Based Criteria and Evaluations.Mapping, developing and performing analysis/validation including SDTM Oncology domains primarily TU (Tumor Identification), TR (Tumor Results) and RS (Disease Response).Reviewing the Protocol, eCRFs, Statistical Analysis Plan (SAP) and specification documents as needed.Produced SDTM domain datasets, ADaM datasets and tables, listings, figures (TLFs) to support the analysis of clinical trials data.Performed data and programed validation to ensure the quality of deliverables met the required internal standards.Review and provide input to project timelines, and ensure that all project timelines are met for both internal and external clients.Familiar with the submission process that includes NDA, IND, ISS, ISE etc.Experience working in different clinical trial phases (Phases I-III).Possess good interpersonal skills with other co-workers and supervisors.HepTronik Corporation Nov17 Jun21Princeton, NJJob Title: SDTM ProgrammerLocation: Celgene/BMS, Berkeley Heights, NJResponsibilities:Experience with CDSIC standards including CDASH or SDTM/ADaM.Assigned to various therapeutic areas (TAs) including Oncology.Serve as Study SDTM Programming lead for all Regulatory Submissions.Partner with CROs and act as a primary point of contact for SDTM programming activities.Oversee and monitor CRO DB Build (in Medidata Rave) to ensure that the standards are implemented across all studies.Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, datasets, define.xml, SDRG, Annotated CRF) for Celgene studies.Design the SDTM specification as per the CDISC SDTMIG and ensure they meet downstream ADaM and Reporting requirements.Familiarity with Celgene SDTM automation tools, macros and using them for SDTM programming.Good understanding of Celgene EDC, SDTM metadata and metadata driven environment.Review the Study EDC specification and ensure all collected study data (including external) is mapped appropriately in target SDTM model.Annotate CRFs and Review annotated CRFs in accordance with Celgene guidelines and appropriate metadata to reflect tabulation datasets.Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros.Oversee development of SAS programs to generate SDTM datasets.Validation of SDTM datasets to ensure meets regulatory compliance.Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and Celgene Quality tools.Provide SME (Subject Matter Expertise) in defining the mapping relationships between source EDC and target SDTM domains.Provide oversight of CRO/vendor programming activities to ensure adherence of standards as well as receiving quality and timely deliverables.Collaborate with stakeholders and Study team members to manage study timelines, and resolve issues.Ability to work closely in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers.Represent SDTM Programming function in Study team meetings as well as cross-functional working groups and process improvement activities.Routine interface with cross-functional team members during the study startup and execution.Provide input to the design of the clinical trial database from an SDTM perspective.Knowledge of clinical study design and experience in CRF design, central laboratories, programming databases, query resolution, data validation.Develop, program, test and maintain clinical trial databases and data entry screens using Medidata Rave in accordance with data standards.Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.Review validation/edit checks for in-house and outsourced studies.Act as liaison with vendors and oversee CRO to establish external data transfer specifications.Retrieve data from CRO and external vendors.Perform post processing of data extracts in accordance with data standards to be delivered to the Biostatistics team (if in-house study).Role: Senior SAS (Clinical) ProgrammerResponsibilities:Working closely and supporting the Data Management and the Statistical Programming teams.Good knowledge on clinical database design using Medidata Rave.Participate during all eCRF design meetings.Develop, program, test and maintain data review listings using SAS.Knowledge of FDA/ICH guidelines and industry standard practices regarding programming.Knowledge of clinical trial design and basic statistics towards analysis.Developing safety and efficacy analysis datasets from raw data and flat files.Experience with the creation/mapping of CDISC SDTM domains and ADaM datasets for various analysis.Experience working with clinical data analysis, and creating tables, listings and figures (TLGs).Creating reports in various formats including RTF, HTML, PDF and XML formats using SAS Output Delivery System (ODS).Creating .XPT files (transport files), DDF files (Data Definition) for e-submission.Creating transport files for CROS/Sponsors submission using SAS procedures Cport and Cimport.Back-up peer programmer per assignment.Act as liaison with vendor to establish transfer specifications and standards.Routinely interface with cross-functional team members.Cognizant Technology Solutions Sep12 Oct17Sanofi AventisBridgewater, NJSAS AnalystResponsibilities:Provide programming and validation for ISS and ISE datasets and preparing Integrated Summaries of Efficacy (ISE) and Safety (ISS) reports.Work effectively within CDISC standards, including Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) environments.Ensuring that all programming deliverables are CDISC and SDTM/ADaM compliant.Develop CDISC SDTM domains in accordance with SOPs, CDISC and industry standard documentation.Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.Contribute to the Creation, Maintenance, and Validation of standards for programming Tools, Outputs and Macros.Contribute towards the creation of the Naming Conventions, Controlled Terminology (CT) and Data Standards, Version Control within the programming environment.Provide data mapping from non-CDISC environment to CDISC SDTM, and also from SDTM to ADaM.Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.Provide programming support for the preparation of Integrated Reports, Submissions and Post-Submission activities.Create define files and converting TFLs to the required format towards e-Submission.Providing analysis SAS datasets and also responsible for modifying, updating and maintaining SAS programs.Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.Perform Adhoc flexible and rapid programming, arising from questions generated from planned analyses and results.Perform programming validation to ensure the quality of analysis datasets and programming outputs.Validate SDTM domain outputs in accordance to the guided specifications.Supported the team with Validation including program validation and independent programming on a regular basis.Proficient with Base SAS, Macros, Proc SQL and Statistical analysis using SAS statements, functions and procedures.Worked on legacy SAS Clinical databases like Oracle Clinical & Clintrial with over 5 years data and performed mapping, conversion and processing of raw data from various databases.Provide input to the design of the clinical trial database for proper data capture and to ensure data quality.Responsible for automating SAS programs & processes to accommodate existing and future SAS datasets.Ensure consistency and adherence to standards within their therapeutic area.Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.Effective project planning and project management skills in an SDLC (Agile) methodology.OckhamCary, NCSenior Statistical Programmer May12 Sep12Responsibilities:Responsible for processing of clinical data required for analysis of clinical trials for Phase 1-3.Familiar with CDISC conventions Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) models and hands on experience implementing these models.Experience with SDTM mapping, related data structures, and programming to create SDTM data setsAnalysis data sets are created to enable the statistical and scientific analysis of the study results.Experience working with ADaM specifications and ADaM/TFL generation.Performed the SDTM mapping after the data is collected into a clinical database.Create SDTM mapping specifications from source raw data to target SDTM dataset and/or data definition files.Generate and validate analysis datasets, (TLGs) tables, listings and graphs for in-house analyses.Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results.Create Data Definition Tables (DDT) and converting TFLs to the required format for eSubmission.Interacting with client personnel, team members and participating in weekly team meetings.INC ResearchRaleigh, NCClinical Programmer Apr10 Apr12Responsibilities:Clinical SAS programming for the Data Management and Bio-statistics departments.Involved with SAS programming for Phase I III clinical trials data in various TAs.Developing dynamic SAS programs using Base SAS, Proc SQL and SAS Macros.SAS programming for project specific requirements and the CRF (Case Report Form).Experience in Clinical Database Design/Development/Programming.Experience working with Medidata Rave, Oracle Clinical, and Inform (Central Designer).Responsible for the development, production and validation of import/export and mapping SAS datasets and also Clinical/data listings for various clients.Generating reports in PDF, CSV and XML outputs using SAS ODS (Output Delivery System).Developing listings for efficacy and safety data.Programming validating and maintaining SAS programs for protocol driven and study specific guidelines in a timely manner for all project deliverables.Interacting with team members and Data Management personnel and participating in team meetings.Worked on Windows platforms with PC SAS and Server SAS environments.i3 StatprobeWesterville, OH Apr08 Mar10Analyst Programmer (SAS)Responsibilities:Worked in an SDD (SAS Drug Delivery) environment for various ongoing studies in Oncology for the clients.Developed, utilized and maintained standard SAS naming conventions for a macro library supportingConsistency and reusability of programs.Participate in the design and maintenance of a standard programming environment (file structure andthe Development, QA to Production implementation strategy).Programming and validation for creation of an IDB (Integrated Data Base) for various studies.Worked extensively on De-identification of SAS data sets.Created Annual Reports and Ad-hoc Reports for various analyses using SAS Output Delivery System (ODS).Developed dynamic SAS programs using Base SAS, Proc SQL, Macros, Statistical procedures & Graphs for Phase IIII Clinical Trial data.Created and maintained analysis datasets from raw data sets using import and export procedures (xls, csv, txt, tab, any DLM).Recognized inconsistencies and initiated resolution of data problems.Performed quality review of datasets prepared by external vendors for the clients.Produced data listings, summary tables and graphs for interim, final analyses and publications.Programming and validating analysis datasets, listings, tables and figures for clinical study reports.Astir IT Solutions Inc.ConsultantSouth Plainfield, NJSAS Statistical Programmer Jun05 Apr08Client # 1Quintiles Inc., Kansas City, MO Oct07 Dec07Statistical Programmer (SAS)Responsibilities:Develop SDTM domains in accordance with SOPs, CDISC guided specification and industry standard documentation.The source data are mapped into multiple SDTM Domains such as Demographics (DM), Subject Visits (SV),Concomitant Medications (CM), Exposure (EX), Adverse Events (AE), ECG results (EG), Laboratory Results (LB), PK concentrations (PC) PK parameters (PP), and Vital Signs (VS).Develop and maintain programs to meet internal and external clients' needs.Plan and coordinate programming, testing, and documentation of statistical programs for use in creating statistical tables, graphics, and listing summaries.Participate in the design and maintenance of a standard programming environment (file structure and development to production implementation strategy).Programming and validating Analysis datasets, Tables, Listings and Figures (TLGs) for inclusion in clinical study reports.Developed dynamic SAS programs using SAS BASE, SAS MACROS, STATS & GRAPHS with Phase I II Clinical Trial data.Client # 2PRA InternationalCharlottesville, VA Jul 05 Sept 07Analysis Programmer (SAS)Responsibilities:Involved in SAS programming with Clinical Trials data for Phase I-III Clinical Trials in Oncology.Developed dynamic SAS programs using SAS Tools like SAS/Base, SAS/Macros.Developed new SAS programs and modified existing SAS programs.Base SAS, Proc SQL and Macros were used extensively in analysis of standard clinical data and generated tables, listings, and graphs.Developed procedures to standardize analysis programs, including a macro library.Developed Tables, Listings and Figures for various on-going studies.Involved with the QC and Validation of SAS programs.Educational Qualifications:Post Graduate Diploma in Computer Applications (PGDCA), Hyderabad, India.Bachelor of Science (B.S) from Osmania University, Hyderabad, India. |
