Principal SAS Programmer

仕事内容

Description

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.

Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.

We do things differently than large CROs and would love to have you join our Veristat team!

The Principal SAS Programmer independently 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 Principal SAS Programmer supports migration activities in the creation of Standard Data Tabulation Model (SDTM) and production of the Analysis Data Model (ADaM). The Principal SAS Programmer is also responsible for monitoring and meeting assigned program milestones, and will coordinate and lead a team of programmers to accomplish tasks.

As a Principal SAS Programmer You Will…

• 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.
• 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 Dataset, Tables, Listings, and Figures following the departmental QC procedures.
• Train and mentor new hires and junior SAS Programmers, following established standardized design and programming procedures.
• Create Define XML; Define PDFs, and Reviewers Guides.
• Apply CDISC knowledge (SDTM and ADaM) standards to dataset programming.
• Consult with Sponsors on technical and/or regulatory issues.
• Provide technical training to other staff members.
• Coordinate quality improvement initiatives.
• 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 Veristat 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.
• Lead individual projects as well as large drug development programs, including integrated summaries of safety and efficacy.
  

Experience + Requirements

• Bachelor’s Degree in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 10 years of SAS programming experience with clinical trial data OR Master’s Degree in in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 8 years of SAS programming experience with clinical trial data.
• Good working knowledge of CDISC SDTM and ADaM Implementation Guidelines.
• Excellent knowledge of regulatory requirements and drug development process.
• Excellent organizational skills and verbal/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.
• Leadership skills to lead project team to deliver high quality deliverables on time and working directly with the Sponsor to meet the project delivery expectations.
• Must be fluent in English (written and verbal).