CDISC Principal SAS Programmer

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Principal CDISC SAS Programmer will work exclusively within Emmes' corporate CDISC Group with primary responsibility for generation of CDISC-compliant data structures for clinical trials. As part of these activities, the Principal CDISC SAS Programmer will map clinical data to SDTM domains following internal Implementation Guides and specific Therapeutic Area Users Guide and work with project teams to create ADaM data structures and any other CDISC materials necessary for regulatory submissions.

Responsibilities
  • 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.
  • Modify and maintain SAS programs written by others.
  • QC SAS programs for Dataset, following the departmental QC procedures.
  • Create Define XML, and Reviewers Guides.
  • Apply CDISC knowledge (SDTM and ADaM) standards to dataset pro gramming.
  • Follow established standardized design and programming procedures (CDISC); provide mentoring t o junior level SAS programmers

Experience
  • Bachelor's degree, scientific discipline preferred with at least 7 years of SAS programming experience in the production CDISC-compliant data structures including SDTM and ADaM; MS/PhD with al least 5 years of relevant experience.
  • SAS Certified Base Programmer and Advanced certifications required
  • Experience with development, documentation, and testing of analysis data and programming code to meet regulatory and company standards
  • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data
  • Study programming lead experience with strong SAS data manipulation, analysis and reporting skills
  • Proficiency in SAS MACRO development
  • Experience in Efficacy analysis
  • Experience with Pinnacle21
  • Submissions experience utilizing define.xml and other submission documents
  • Ability to provide quality output and deliverables, in adherence with challenging timelines
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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