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Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLE Phone: PHONE NUMBER AVAILABLE Street Address LINKEDIN LINK AVAILABLEResume: Candidate's Name
pg. 1P R O F E S S I O N A L S U M M A R YSeasoned professional with many years of SAS programming experience, the ability to organize information concisely and effectively, and extensive knowledge of multiple programming languages. Outstanding ability to work with and supervise others and skilled at establishing and complying with protocols and procedures following GxP requirements. Moreover, perform or assist with all statistical programming-related activities while ensuring the integrity of the data and analysis by adhering to all applicable regulatory requirements, and following CDISC specifications to create compliant datasets.S K I L L S S U M M A R YOperating Systems: Unix, Windows.Computer Languages and Scripts: SAS (over 20 years in the Pharmacology industry using SAS Stat, SAS Base, SAS Macros, SAS ODS, and SAS Graph, fourteen years total experience), Fortran, Pascal, C/C++, HTML/XHTML. Studies: Phases1 to 4 for Oncology (Pancreatic Cancer, Lymphoma, & other cancers, used PROC LIFETEST & PROC MIXED), Infantile Jaundice, Diabetes mellitus, Ophthalmology, Skin Conditions (PSORIASIS, ACNE, Warts), Bipolar I Disorder (Schizophrenia), Systemic Lupus Erythematosus (SLE), COVID-19, and numerous other studies. Apps and Database Management: Microsoft Office, Access. Other skills: Experienced with diagnosing, isolating, and resolving complex problems. Experienced with managing client data requests/issues. Experienced with discerning requirements for analysis, hands-on design, and development. Experienced with working with Medicaid data. Experienced with communicating and working with individuals and teams across multiple levels. Created the PROC GENMOD macro to use the SAS PROC GENMOD and the SCATPLOTUL Macro to produce a scatterplot with boundaries showing upper and lower normal ranges. Worked with the Medicare data. P R O F E S S I O N A L E X P E R I E N C ECTI Clinical & Trial Consulting, Covington, KY January 2023 to February 2024 Statistical Programmer IIAs a statistical programmer on the studies assigned, perform the following tasks (80%)Assist with SDTM naming conventions for database build specifications.Develop SDTM dataset specifications and assist with the development of ADaM dataset specifications and table, listing and figure (TLF) shells needed to perform the analysis defined in the Statistical Analysis Plan(SAP) following CDISC-compliant dataset creation and formatting.Review/develop SDTM-annotated CRFs.Perform the statistical programming to create SAS dataset deliverables, including SDTM and ADaM datasets, per dataset specifications.Review Pinnacle 21 findings and generate Reviewers Guide and Define.xml files.Review the SAP and the TLF shells, and provide feedback to the statisticians.Perform the statistical programming to create TLFs per mock TLF shells.Perform data transfer activities between SAS and various databases and data file formats for internal team members (e.g., Clinical Data Management, Safety) and external clients (e.g., third party vendors, central labs), including file reconciliations.Perform statistical programming to review data for protocol adherence, coding consistency and plausibility.Collaborate with management to develop and refine departmental SOPs relating to statistical programming (1%).Carry out all activities according to CTI SOPs and project specific conventions within the framework of Good Clinical Practice/ICH guidelines.Rely on instructions and Biostatistics SOPs to ensure timely, standard, quality deliverables to customers (3%).Maintain accurate records of all work performed and ensure all relevant statistical programming documents are filed in the eTMF per the project-specific eTMF plan (16%). Candidate's Name PAGE 2Resume: Candidate's Name
pg. 2ICON Government and Public Health Solutions, Blue Bell, PA August 2020 to October 2022 Statistical ProgrammerAbility to work on several pharmaceutical deliverables in a timely manner and create macros to increase the proficiency of the programs.Supports development of table, listing, and figure shells (45%).Supports development of deliverables (project reports and outputs, datasets, tables, listings, & figures) (4%).Develop SAS programs to check the COVID data for Data Management department (2%).Program and validate CDISC datasets (SDTM, ADaM) and required documentation (42%).Creates derived variables from written or oral specifications with oversight (5%).Programs specialized statistical procedures (repeated measures, survival analysis, etc.) & SAS/Graph (1%).Supports development of complex macros for use by the department (1%). BIORASI, Aventura, FL June 2018 to October 2019Associate Statistical ProgrammerAbility to work on several pharmaceutical deliverables in a timely manner and create macros to increase the proficiency of the programs.Primary Responsibilities:Program from specifications primarily using SAS programs for the creation or validation of SDTM domains, ADaM datasets and TLFs (tables, listings and figures) for clinical trials (95%).Read and comprehend programming specifications for data validation, transformations, analysis programs, and using Pinnacle 21 to create analysis datasets and statistical outputs (3%).Assist with the documentation of data and outputs for delivery to sponsors. This includes CDISC compliant metadata in the form of annotated CRFs, Define.XML and Data Reviewers Guides (1%).Understand and develop/validate programs using descriptive statistics (1%).Secondary Responsibilities:Run data analytics programs to assess data quality and consistency across sites in support of clinical monitoring, project management and safety.Communicate as necessary with statisticians and data management personnel. E D U C A T I O NNORTH CAROLINA STATE UNIVERSITY, Raleigh, NC December 1983 B.Sc., BiochemistryAPPALACHIAN STATE UNIVERSITY, Boone, NC May 1978B.Sc., Special EducationDUKE UNIVERSITY, Durham, NCContinuing Education, Computer Programming classes C E R T I F I C A T E SDURHAM TECHNICAL COMMUNITY COLLEGE, Durham, NC July 2013 Certificate in Clinical Trials Data ManagementP E R S O N A L A C H I E V E M E N T SSupervisor of the Department of Medicine, Division of Neurology Tissue Culture/DNA Bank Facility at Duke University for five years.Boy Scouts of America: Eagle Scout, Mawat Award for Merit, Mawat District Commissioner. Duke University Medical Center Performance Award.Duke University Medical Center Exceptional Appreciation certificate. Dean's List at NCSU and ASU. |
