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Statistical Programmer Resume Samples
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0-5 years of experience
- Programmed online research surveys using Python, JavaScript, and XML.
- Cleaned and organized data in Excel and R.
- Performed statistical analyses in R.
- Wrote scripts in Python to automate text changes and formatting, saving company time.
0-5 years of experience
Work independently in one of the largest CRO global company.
- Develop and execute statistical analysis plans including generation or validation of tables, listings, and figures and generate reports according to Client requirements.
- Produce or validate analysis datasets and TFLs for ISS.
- Develop or validate mapping datasets and derived datasets in multiple projects. Contributed to the development and validation of SDTM and ADaM datasets. This was the first project of its kind for my department recognized by the client (one of the top pharmacy companies) as the CRO of the quarter in 2010
- Work directly with Lead Data Managers in making data reconciliation reports, developing and reviewing listings and reports.
- Gave CDISC presentation as part of team for Covance. Attended the CDISC Interchange in MD in Oct. 2007.
- Extract, transmit and retrieve data from clients and generate SAS datasets including SDTM, or DDT needed for the FDA.
0-5 years of experience
- Constructed simulation algorithm in R to optimize recruitment of the patient population for an analgesic Phase III Clinical Trial
- Conducted analyses of non-inferiority, cut points for statistical significance, and sample size
- Generated summary graphics of patient population characteristics throughout recruitment
- Assisted in validating and replicating dry-run tables and figures from Contract Research Organization (CRO) analysis of trial data
0-5 years of experience
- Generated draft and final sets of summary data tables and analyses as part of clinical study reports and ISS/ISE documents for regulatory submission.
- Wrote project-specific programming code to produce summary data tables and analyses, as specified in statistical analysis plans.
- Developed utility SAS macros for use in project programs.
- Validated SAS macros and derived data sets developed by other programmers.
- Created Submission Datasets in CDISC SDTM and Analysis Datasets in CDISC ADaM standards.
0-5 years of experience
As a SAS Programmer/Analyst involved in double blind, multi- center randomized Phase III clinical study in the Oncology area.
- Responsible for database management and SAS programming for statistical analysis, documentation, and reporting.
- Involved in Statistical summary tables, analysis data sets and patient data listings. Proficient in handling programs, logs, listings, data sets, and transport files.
- Used SAS/STAT Procedures such as PROC MEANS, PROC UNIVARIATE, and PROC FREQ to develop SAS programs to process clinical trial data on Windows environment.
- Performed quality reviews and validations of SAS programs (SDTM and ADaM datasets, tables and listings) generated by other SAS programmers. Followed good programming practices and adequately document programs.
- Reviewed CRFs to make sure all the data collected are uploaded to the database by printing all the variables for each data set.
- Attended project team meetings, worked with biostatisticians, data managers, and clinical research managers, as appropriate.
- Provided SAS programming support by generating analysis data sets, tables and listings for important deliverables such as IND annual reports, Investigator Brochure (IB), Annual and Quarterly Safety reports and ad-hoc reports.
- Generated protocol deviation reports for different studies and data review reports for data cleaning purpose and independent abnormality reports.
0-5 years of experience
- Designed database structure and created an SQL database for complex clinical data, and allocated the rights for different users.
- De-indentificated all transcriptions with “gold standard” to protect privacy for patients.
- Automated above processing with developing a user-friendly system for VIVA to import, export, search, add, delete or edit all the data.
0-5 years of experience
- Led the selection process and deployment of Clintrial 4, the clinical data management system, a critical capability for the start-up company
- Integrated the SAS System for statistical data processing, another critical capability for the start-up company
- Statistical programmer for clinical trials, performing data analysis, mapping, cleaning, and profiling
0-5 years of experience
Perform as SP lead and QC lead in multiple studies: interact with biostatisticians, clients and other programmers to fulfill numerous deliveries.
- Programming on SDTM, Adam SAS and statistical outputs by specification, CRF and SAP
- Review specification before deliveries to make sure they can be realized in programming.
- Be proactive to discuss any possible issue before or after data transfers.
- Check data issue and make document to make sure that they can be fixed by DM department.
- Manage project budget and propose or try any idea which can make work efficient.
6-10 years of experience
- Used I-Review to extract SAS Datasets, analyze data and generate reports.
- Designed detailed project plan and schedule to meet the tight regulatory submissions’ deadlines.
- Used SAS programming to generate analysis datasets, pooled datasets, listings, tables, and figures for phase I-IV clinical trials including FDA requests and submission studies.
- Made certain that documents and specifications were consistent and comply with company standards by providing input as required at all meetings, discussions and activities covering aspects of Statistical Reporting on trial level activities.
- Supported team members of SR and program statisticians in maintaining efficient interfaces with internal and external customers.
- Used SAS programming to generate PDF simulations of data entry screens for site archives and further refined PDFs by creating page and visit level bookmarks for regulatory submissions to FDA.
- Provided ongoing support of EDC(Electronic Data Capture) based clinical trials performing quality check of patient profiles.
- Used EXCEL, ACCESS, Oracle Database and Adobe Acrobat including addition of bookmarks to generate patient profiles.
- Performed clinical development process using Oracle SQL and PL/SQL.
- Received Business Excellence Award for meeting challenging deadlines with excellent quality work.
0-5 years of experience
- Used SAS to create CDISC-compliant datasets
- Developed and validated SAS macros to streamline and standardize departmental workflow
- Communicated with data managers and statisticians to meet client and regulatory requirements
- Handled sensitive data in a regulated environment to maintain patient and client confidentiality
10+ years of experience
- Prepare Human Growth Hormone registry data for processing by organizing information, checking for any inaccuracies, and adjusting and weighting the raw data.
- Provide statistical and programming support to manuscript authors, medical writers and clinicians with respect to Growth hormone registry publication strategies. Collaborate with medical information scientists to respond to patient information requests.
- Report phase 2 and phase 3 clinical trial results of statistical analyses, including information in the form of graphs, charts, and tables (TFLs)
- Respond to FDA and Health Canada requests for data to support Drug Applications.
- Validate NDA submission data (SDTM) and summary documents including Clinical Trial Reports, Integrated Summary Safety (ISS) and Integrated Summary Efficacy (ISE).
- Provide statistical programming support in negotiations to divest Inflammation portfolio.
- Manage data migration from SAS 8.1 to SAS 9.1 Unix 64 bit architecture. Develop procedures and document the migration and validation processes.
0-5 years of experience
- Lead statistical programming activities for publications from multiple phase III trials.
- Core programmer for a phase III study of BTK inhibitor in naïve CLL patients leading to an FDA approval.
- Provide programming support for IRC, CSR productions, NDA submissions, and reponses to FDA questions.
- Create CDISC SDTM and ADaM datasets to use for the electronic submission to regulatory agencies.
- Interact with other study team members to conduct data analysis.
- Manage the assignments of internal and external contractors.
0-5 years of experience
- Represent the the Biostatistics department on project teams.
- Perform all SAS programming required for clinical trial analysis and reporting. Assist with statistical quality assurance review and program validation for each project.
- Meet with Project Managers, biostatisticians and clients to determine reports and statistics to ensure a high level of client satisfaction
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Last edited by: Gabriela Barcenas, CPRW, Content Writer II -
Gabriela Barcenas
CPRW, Content Writer IIGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
