MedFocus SAS Programmer /Analyst in Massachusetts
Job Description: Our client seeks a Principal level SAS programmer to independently lead the programming activities for various purposes including CSRs, DSMBs, interim analyses, manuscripts, etc. Mainly supports statistical programming of statistical analysis plan (SAP)-planned tables, data listings, and graphs for CSRs, as well as integrated summaries of safety and efficacy, ad hoc analyses and electronic submission deliverables, such as datasets, data documentation, programs, programming table of contents, and patient profiles. In addition, the Principal SAS Programmer supports migration activities in the creation of Standard Data Tabulation Model (SDTM) and production of the Analysis Data Model (ADaM). This role also responsible for monitoring and meeting assigned program milestones and may lead a team of programmers to accomplish tasks.
Design or write program specifications based on consultations with Bio-statistical programming and Bio-statistical staff.
Lead Programming Project teams by assigning tasks, reviewing their programs, and working with business partners and the client to establish timelines for all deliverables.
Convert 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.
Mentor new hires and all level SAS Programmers.
Create Define XML, Define PDFs, and Reviewers Guides.
Mentor and train junior-level SAS Programmers.
Lead individual projects as well as large drug development programs, including integrated summaries of safety and efficacy.
Apply CDISC knowledge (SDTM and ADaM) standards to dataset programming.
Consult with Sponsors on technical and/or regulatory issues.
Coordinate quality improvement initiatives.
Follow established standardized design and programming procedures; 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; develop and maintain clinical processing work flow systems; assist in the development of client proposal documents; and represent company at client technical meetings.
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.
Please send resume to email@example.com
Bachelor’s degree in Computer Science, Computer Information Systems, Statistics, or related field. Master’s degree preferred
10 years of SAS programming experience with clinical trial data required.
Excellent working knowledge of CDISC SDTM Implementation Guidelines, ADaM Implementation Guidelines, regulatory requirements, and the drug development process.
Prior experience working with Data Management on edit checks etc is preferred
General knowledge of regulatory requirements and drug development process preferred
Min Salary: $0.00
Max Salary: $0.00