Executive Director Clinical Data Engineering & Analytics
Overview
Strategic leader delivering modernization of programming support through SDTM for clinical pharmacology and biomarker studies. Oversees global teams and drives AI-readiness while ensuring regulatory compliance and data governance excellence.
What You'll Do11
- 1Develop and implement forward-looking clinical programming innovation vision integrating AI machine learning automation visual analytics and cloud computing to improve quality speed and efficiency
- 2Lead global offshore teams managing clinical data standards safety governance operations visualizations clinical programming SDTM disclosures eSubmissions and Clinical Pharmacology activities
- 3Drive continuous improvement adopting modern languages tools like R Python cloud analytics Git GitHub automated testing frameworks
- 4Implement advanced visual analytics solutions enabling near real-time exploration interactive dashboards and decision support tools enhancing data quality oversight
- 5Ensure CDISC standards consistency contribute to internal metadata library evolution
- 6Advocate global clinical data standards supporting adherence across study teams
- 7Create centralized CDS data strategy with phased roadmap prioritizing compliance business value FAIR principles and AI-readiness using hub-and-spoke model
- 8Partner with Clinical Development Data Management Biometrics ARC Development Systems and IT to optimize end-to-end data flows from study start-up through submissions
- 9Own budgets and resource plans for large portfolios of studies teams overseeing high-quality project deliverables
- 10Supervise people leaders at multiple levels delegating coaching and providing career development opportunities
- 11Navigate global teams across time zones to ensure on-time delivery
Requirements17
- 1Excellent verbal and written communication skills strong negotiation and interpersonal abilities
- 2Deep knowledge of drug development process regulatory expectations and industry standards for programming data structures and reporting
- 3Proven ability to supervise people leaders delegate coach and provide feedback
- 4Experience working with global teams overcoming time zone challenges
- 5Ability to provide statistical programmers structured frameworks for decision making
- 6Exceptional judgment and problem solving skills in complex situations
- 7Lead strategic initiatives and innovations within statistical programming implementing infrastructure improvements enhancing compliance efficiency and quality
- 8Integrate planning efforts with cross functional partners to ensure organizational effectiveness
- 9Influence decision making and negotiate timelines and requirements
- 10Advise senior leadership on programming strategy functional needs and technology modernization
- 11Serve as visible change leader guiding teams through transformation fostering continuous improvement innovation and operational excellence
- 1216+ years relevant industry experience in programming supporting biopharmaceutical data
- 13Extensive experience with SAS R or Python and industry standard programming tools
- 14Proven track record applying AI machine learning advanced automation in data science or statistical programming environments
- 15Hands-on experience with AI-assisted IDEs such as Cursor Claude Kiro
- 16Demonstrated leadership in driving adoption of standards
- 17Participation in CDISC PHUSE ASA R Consortium or similar external working groups
Salary Insight
$281 - $364k per year
Location
Required Skills
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