Senior Statistical Programmer

Role Overview

We are seeking a highly experienced Senior Statistical Programmer / Clinical Data Architect with 15+ 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.

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Key Responsibilities

Clinical Data Programming & Regulatory Submissions

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

Data Engineering & Automation

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

Cloud & Platform Engineering

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)

Leadership & Stakeholder Management

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

Compliance & Governance

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

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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

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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

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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