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Diverse Lynx
Raleigh,NC

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Diverse Lynx
Raleigh,NC

Description

SAS Viya Developer

We are seeking a highly experienced SAS Viya developer with experience between 5 to 10 years of expertise in clinical data programming, CDISC standards, and cloud-based analytics platforms.

The ideal candidate will lead end-to-end clinical data workflows, regulatory submissions, and modern data platform transformations in GxP-regulated environments.

This role requires strong domain expertise in SDTM, ADaM, regulatory submissions, and SAS/Python/R programming, combined with experience in cloud platforms (AWS/Azure) and clinical data modernization initiatives.

Key Responsibilities

  • Design, develop, and validate SDTM and ADaM datasets in compliance with CDISC standards
  • Lead generation of define.xml, aCRF/eCRF annotations, and submission-ready deliverables
  • Develop and optimize automated submission pipelines for FDA and global regulatory authorities
  • Ensure compliance with GxP, 21 CFR Part 11, HIPAA, and ICH E6 guidelines
  • Architect and implement end-to-end clinical data pipelines using SAS, Python, and R
  • Develop reusable SAS macro libraries and automation frameworks
  • Build scalable data pipelines including modern formats (JSON/XPT alternatives)
  • Drive migration from legacy systems to modern data architectures
  • Lead implementation and optimization of SAS Viya platforms on AWS/Azure
  • Manage cloud infrastructure components (EKS, EC2, EFS, FSx, Databricks, etc.)
  • Implement FinOps practices for cost governance and optimization
  • Evaluate and onboard next-gen analytics platforms (e.g., Databricks)
  • Lead cross-functional teams across US, UK, and offshore locations
  • Collaborate with clinical, statistical, regulatory, and IT stakeholders
  • Drive Agile delivery and sprint planning for data and platform initiatives
  • Manage vendor relationships, tool selection, and licensing strategies
  • Ensure adherence to regulatory and audit requirements (FDA, OCC, SOX, Basel III as applicable)
  • Maintain audit-ready documentation and validation processes
  • Implement data governance, traceability, and reproducibility standards

Required Qualifications

  • Bachelor's or Master's degree in Computer Science, Statistics, Life Sciences, or related field
  • 15+ years of experience in statistical programming and clinical data management
  • Strong expertise in: SAS (Base, Macro, SQL, ODS, STAT, Graph), CDISC standards (SDTM, ADaM, define.xml), Regulatory submissions (FDA, global agencies)
  • Hands-on experience with: Python (Pandas) and/or R (admiral, Shiny), Cloud platforms (AWS/Azure)
  • Strong understanding of GxP and clinical compliance frameworks

Preferred Qualifications

  • Experience with SAS Viya architecture and administration
  • Familiarity with Databricks, DBT, or modern data engineering tools
  • Knowledge of CI/CD tools (Jenkins, Git)
  • Experience in financial/regulatory environments (Basel III, CCAR, OCC) is a plus
  • AWS or cloud certifications

Key Skills

  • Clinical Data Standards: SDTM, ADaM, CDISC
  • Programming: SAS, Python, R, SQL
  • Cloud: AWS, Azure
  • Tools: Pinnacle 21, Git, Jenkins, Power BI, Grafana
  • Methodologies: Agile, DevOps, Data Governance

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.


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