SAS Programmer I
Working under the direction of the Biostatistician, senior-level SAS Programmer and/or Manager, the SAS Programmer 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 supports migration activities in the creation of Standard Data Tabulation Model (SDTM) and production of the Analysis Data Model (ADaM).
Primary Duties + Responsibility:
- Participation on projects dealing with the 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.
- Apply CDISC knowledge (SDTM and ADaM) standards to dataset programming.
- 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 & Minimum Requirements:
- Bachelor’s Degree in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 1 year of SAS programming experience with clinical trial data.
- Familiarity and interest in statistical programming techniques and standards, such as CDISC SDTM and/or ADaM.
- General knowledge of regulatory requirements and drug development process.
- Excellent organizational skills and good verbal and written communication skills.
- Strong communication skill set with peers and business partners.
- Strong data analysis skills.
- Must be fluent in English (written and verbal).
- Driving/Travel requirements – 0-10%
- Physical requirements – ability to occasionally lift/move up to 25 lbs.
- Hours/Conditions – US & Taiwan: 40 hour work week;
- FLSA Classification – Exempt