, , 100 Montgomery St. 10th Floor(555) 432-1000, resumesample@example.com
Education
Expected in 05/2016Bachelor of Science | Biomedical SciencesUniversity of North Carolina, Pembroke, NCGPA:
Skills
ISS
Production of SDTM/ADaM/TLF
QC of SDTM/ADaM/TLF
Structured Query Language
ODS
Macro Programming
Professional Summary
Highly-educated Senior SAS(Statistical Analysis Software) Clinical Programmer with commitment to excellence and more than 5 years of experience. Involved in programming Integrated Summary of Safety(ISS). Extensive experience in working with Phase I-III trials, creating and validating Define.XML, SDTM(Study Data Tabulation Model), ADaM(Analysis Data Model), TLF(Tables, Listings, Figures), using ODS(output delivery system), annotating CRF/table shell and specification building for SDTM and ADaM. Extensive understanding of Clinical Data, Trial Design, SAP(Statistical Analysis Plan), CRF(case report form), study protocol and management of clinical programmers. Logical and professional with excellent problem-solving skills.
Certifications
SAS Certified Clinical Trials Programmer Using SAS 9
Work History
06/2018 to CurrentSr. Clinical SAS Programmer Emmes | Rockville, MD,
Participate in projects dealing with assessment, design and/or implementation of data standards (e.g., CDISC SDTM and CDASH).
Perform Gap Analysis on studies requiring migration to CDISC standards to ensure all documentation and datasets necessary to perform the migration activities are present and without issue. Work with the migration team and client to resolve any issues.
Annotate case report forms (CRFs) according to the CDISC Implementation Guideline for migration to SDTM.
Create SDTM specifications document based on CDISC Implementation Guideline.
Follow standardized SDTM migration programming procedures to create quality Standard Data Tabulation Model (SDTM) compliant SAS datasets and Define.XML documents
Create analysis datasets (e.g., ADAM) specifications based on Statistical Analysis Plan (SAP) or any study analysis algorithm.
Convert analysis datasets specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs.
Analyze SAS code to find causes of errors and revise programs.
Write and maintain documentation of changes to SAS code, programs, and specifications.
Revise programs for corrections, enhancements, or system environment changes.
Coordinate with other programmers about program revisions.
Modify and maintain SAS programs written by others.
QC SAS programs for Dataset, Tables, Listings, and Figures following the departmental QC procedures.
Create Define XML, Define PDFs, and Reviewers Guides.
Apply CDISC knowledge (SDTM and ADaM) standards to dataset programming.
Follow established standardized design and programming procedures (CDISC); provide mentoring to junior level SAS programmers.
Assist in establishing standardized programming procedures and work instructions; develop, enhance, evaluate, and validate standardized macros and utility programs; ensure that regulatory requirements are met through validation/compliance activities.
Create statistical analysis outputs to be used in support of final reports, abstracts, posters, manuscripts, and other clinical publications; support systems to produce electronic regulatory submissions.
Managed team of 5 employees, overseeing hiring, training, and professional growth of employees
Prepared a variety of different written communications, reports and documents to ensure smooth operations
Validated SDTM/ADaM using Pinnacle 21
Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork
06/2016 to 04/2018SAS ProgrammerCommunity Legal Aid & Affiliate | Worcester, MA,
Prepare the electronic submission of clinical trial data to regulatory authorities.
Contribution to and review of statistical analysis plans and analysis datasets specifications.
Creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.
Anticipate statistical programming resource needs and work with management to ensure adequate long-term resource allocation within a project.
Provide effective solutions for complex statistical programming tasks.
Provide input or lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions).
Create and manage the project and study electronic subdirectories ensuring consistency in structure.
Contribute to the design, creation, and validation of global programming macros that streamline programming activities and increase efficiency.
06/2015 to 05/2016Data Management AssistantData Analytics And Research | City, STATE,
Identify problems with data quality and communicate issues with program staff and supervisors
Reviewed source documents and listings to compile resources for identifying and correcting data allocation issues
Assist with regular data review and cleanup to maintain overall data integrity
Create routine statistical reports for program data summaries
Participate in staff meetings, as appropriate and as schedule allows
Analyzed content access, retention and evaluation projects to maintain nonstop information repository
Performed systems and data analysis using variety of computer languages and procedures
06/2010 to 05/2015Human Resources AssistantTriangle Trinity Realty | City, STATE,
Supports human resources processes by administering tests, scheduling appointments, conducting orientation, maintaining records and information
Submits employee data reports by assembling, preparing, and analyzing data
Maintains employee information by entering and updating employment and status-change data in a spreadsheet
Provides secretarial support by entering, formatting, and printing information
Answers the telephone, relays messages, and maintains equipment and supplies
Maintains employee confidence and protects operations by keeping human resource information confidential
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