SAS Clinical data programming with Viya exp

Role: SAS Clinical data programming with Viya exp

Location: Raleigh, NC -Onsite

Duration:6 Months

Role Overvie

wWe 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 Responsibiliti

esClinical Data Programming & Regulatory Submissio

ns• Design, develop, and validate SDTM and ADaM datasets in compliance with CDISC standar

ds• Lead generation of define.xml, aCRF/eCRF annotations, and submission-ready deliverabl

es• Develop and optimize automated submission pipelines for FDA and global regulatory authoriti

es• Ensure compliance with GxP, 21 CFR Part 11, HIPAA, and ICH E6 guidelin

esData Engineering & Automati

on• Architect and implement end-to-end clinical data pipelines using SAS, Python, and

R• Develop reusable SAS macro libraries and automation framewor

ks• Build scalable data pipelines including modern formats (JSON/XPT alternative

s)• Drive migration from legacy systems to modern data architectur

esCloud & Platform Engineeri

ng• Lead implementation and optimization of SAS Viya platforms on AWS/Azu

re• Manage cloud infrastructure components (EKS, EC2, EFS, FSx, Databricks, etc

.)• Implement FinOps practices for cost governance and optimizati

on• Evaluate and onboard next-gen analytics platforms (e.g., Databrick

s)Leadership & Stakeholder Manageme

nt• Lead cross-functional teams across US, UK, and offshore locatio

ns• Collaborate with clinical, statistical, regulatory, and IT stakeholde

rs• Drive Agile delivery and sprint planning for data and platform initiativ

es• Manage vendor relationships, tool selection, and licensing strategi

esCompliance & Governan

ce• Ensure adherence to regulatory and audit requirements (FDA, OCC, SOX, Basel III as applicabl

e)• Maintain audit-ready documentation and validation process

es• Implement data governance, traceability, and reproducibility standar

ds
Required Qualificati

ons• Bachelor’s or Master’s degree in Computer Science, Statistics, Life Sciences, or related fi

eld• 10 years of experience in statistical programming and clinical data managem

ent• Strong expertise

in:o SAS (Base, Macro, SQL, ODS, STAT, Gra

ph)o CDISC standards (SDTM, ADaM, define.x

ml)o Regulatory submissions (FDA, global agenci

es)• Hands-on experience wi

th:o Python (Pandas) and/or R (admiral, Shi

ny)o Cloud platforms (AWS/Azu

re)• Strong understanding of GxP and clinical compliance framewo

rks
Preferred Qualificat

ions• Experience with SAS Viya architecture and administra

tion• Familiarity with Databricks, DBT, or modern data engineering t

ools• Knowledge of CI/CD tools (Jenkins,

Git)• Experience in financial/regulatory environments (Basel III, CCAR, OCC) is a

plus• AWS or cloud certificat

ions
Key S

kills• Clinical Data Standards: SDTM, ADaM,

CDISC• Programming: SAS, Python, R

, SQL• Cloud: AWS,

Azure• Tools: Pinnacle 21, Git, Jenkins, Power BI, Gr

afana• Methodologies: Agile, DevOps, Data Gover