Senior SAS Programmer - Clinical Data Management

Key Purpose :

The Senior SAS programmer leads the programming activities for various purposes includingCSRs, 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 Senior SAS Programmer supports migration activities in the creation of

Standard Data Tabulation Model (SDTM) and production of the Analysis Data Model (ADaM). The Senior SAS Programmer is also responsible for monitoring and meeting assigned program milestones and will lead a team of programmers to accomplish tasks.

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.

• 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 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.

• Mentor new hires and more junior SAS Programmers.

• 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 & Minimum Requirements :

• Bachelor's Degree 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 OR Master's 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.

• Leadership skills to lead project team to deliver high quality deliverables on time and work directly with the Sponsor to meet the project delivery expectations.

• Must be fluent in English (written and verbal).