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 Senior 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 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
- Review protocols for CDISC conformance
- Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements
- Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with Emmes' SDTM Implementation Guide, project standards, and the study protocol
- Create DEFINE specifications for mapping of SDTM and ADaM compliant datasets
- Review and QC submission ready SDTM datasets, define.xml, and supporting documentation, as appropriate
- Prepare and validate submission packages, i.e. define.xml, Reviewers Guide
- Provide CDISC training and serve as a subject matter support to project staff
- Maintain and coordinate CDISC standards efforts, ensure maximum reuse of applied standards, involvement in ongoing process improvement efforts and working with teams to provide technical and process guidance
- Stay current with the evolution of all CDISC standards and be involved in creation and maintenance of process documentation
- Other duties as assigned
- Bachelor's degree, scientific discipline preferred with at least 4 years of SAS programming experience in the production CDISC-compliant data structures including SDTM and ADaM
- 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
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares
community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
- 401k & Profit Sharing Plan
- Work From Home Anywhere in the US
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- Casual Dress Code & Work Environment
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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.