Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons Teamnt@penfieldsearch.com
Job Description: The SAS programmer leads 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 SAS Programmer supports migration activities in the creation of Standard Data Tabulation Model (SDTM) and production of the Analysis Data Model (ADaM). The SAS Programmer is also responsible for monitoring and meeting assigned program milestones and will lead a team of programmers to accomplish tasks.
- Participate in 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.
- 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.
Experience + Requirements:
- Bachelors Degree in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 6 years of SAS programming experience with clinical trial data OR Masters Degree in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 6 years of SAS programming experience with clinical trial data.
- Good working knowledge of CDISC SDTM and 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 lead programming teams.
- Strong communication skill set with peers, business partners, and Sponsors.
- Strong Analytical mindset.
- Must be fluent in English (written and verbal).