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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expert-level proficiency in programming languages such as Python, R, SAS, and SQL, along with a deep understanding of clinical data programming and data engineering. Capable of driving automation, advanced analytics, and ensuring compliance with regulatory standards in clinical development.
Highest-signal resume keywords
Expert-Level Proficiency In PythonExpert-Level Proficiency In RExpert-Level Proficiency In SASExpert-Level Proficiency In SQLExperience With Cloud-Based Pipelines
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Data ProgrammingData EngineeringData Management GovernanceAnalytical ToolsForecasting ToolsInteroperability StandardsData Integration EnvironmentsSDLC/CSV KnowledgeRisk-Based Data PracticesDrug Discovery Processes
Soft Skills
Strategic LeadershipPeople LeadershipMentoringStakeholder ManagementNegotiation Skills
Tools & Technologies
Azure Data FactoryAWS GlueDatabricksEDC PlatformsCloud Computing Platforms
Industry Keywords
FDA RegulationsGxP GuidelinesICH GuidelinesClinical OperationsAudit Readiness
Tech Stack
Tools & technologiesAWSAzureCloudPythonSDLCSQL
About the role
Key responsibilities & impact- Define and execute the long-term programming and reporting strategy for data integration, reporting, automation, and analytics across therapeutic areas
- Establish and continuously improve programming and reporting standards, frameworks, and operating models
- Manage service provider partnerships and ensure adherence to enterprise processes, audit readiness, and quality benchmarks
- Oversee programming and reporting delivery across multiple complex studies and projects with accuracy, efficiency, and regulatory compliance
- Provide subject matter expertise on programming and reporting strategies, data engineering, and data flow across clinical data systems
- Shape the strategy for programming and reporting capabilities developed by DI&A
- Collaborate with senior leadership on capacity planning and competency growth for Data Architects
- Own development of critical tools, processes, and skills aligned with industry best practices
- Champion automation, continuous improvement, and metadata-driven development
- Drive AI/ML, advanced analytics, and data virtualization initiatives
- Solve operational challenges through engagement, facilitation, mentoring, and expert problem-solving
- Evaluate and implement process and technology improvements for scalability, standardization, and quality
- Translate complex technical insights into strategic, actionable outcomes
- Partner with GDMS and cross-functional teams to align priorities and deliver coordinated outcomes
- Oversee regional risk, escalation, and capacity management processes and ensure compliance with local regulations
Requirements
What you’ll need- Bachelor's Degree with a minimum of 10 years’ experience in clinical data programming, data engineering, or related data-management/clinical operations functions, plus deep subject matter expertise in clinical development
- Advanced Degree (Masters or Doctorate) with a minimum of 8 years’ experience in clinical data programming, data engineering, or related data-management/clinical operations functions, plus deep subject matter expertise in clinical development
- Expert-level proficiency in programming languages such as Python, R, SAS, and SQL
- Expert knowledge of standards and enterprise data management principles
- Expert knowledge of interoperability among EDC platforms, data integration environments, clinical operations systems, and cloud computing platforms
- Experience designing or managing cloud-based pipelines such as Azure Data Factory, AWS Glue, and Databricks
- Demonstrated success managing outsourced programming operations and global delivery partners
- Deep understanding of end-to-end data management governance, clinical operations, operational metrics, and quality frameworks
- Proven track record implementing risk-based and digital data practices across regions
- Advanced use of analytical and forecasting tools
- Operating knowledge of SDLC/CSV, data privacy, and inspection-readiness requirements
- Deep knowledge of drug discovery processes, FDA regulations, and GxP / ICH guidelines
- Strategic leadership, people leadership, mentoring, and development capabilities
- Advanced stakeholder management and negotiation skills
- No visa sponsorship available
- US and Puerto Rico residents only
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Hybrid work arrangement
