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Working under the direction of the Biostatistician, senior-level SAS Programmer and / or Manager, the SAS Programmer II aids 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 SAS Programmer II supports migration activities in the creation of Standard Data Tabulation Model (SDTM) and production of the Analysis Data Model (ADaM).
As a SAS Programmer II You Will...
Design or write program specifications based on consultations with Biostatistical programming and Biostatistical 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 Datasets, Tables, Listings, and Figures following the departmental QC procedures.
Mentor new hires and junior SAS Programmers.
Assist in creation of 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.
Experience + Requirements
Bachelor’s Degree in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 4 years of SAS programming experience with clinical trial data.
Programming experience with clinical trial data.
Good working knowledge of CDSC SDTM Implementation Guidelines.
Good working knowledge of CDISC ADaM Implementation Guidelines.
General knowledge of regulatory requirements and drug development process.
Excellent organizational skills and good verbal and written communication skills.
Ability to work independently as well as collaborate with teams is required.
Strong communication skill set with peers and business partners.
Strong data analysis skills.
Leadership skills to lead project team to deliver high quality deliverables on time.