Principal Scientist, Stat. Programming – A&R Standards, Innovation

• Support the strategic design, development, and delivery of efficient, flexible, modular analysis and reporting and submission standards and tools for drug and vaccine projects
• Drive development and adoption of a scalable, reusable multilingual standards library based on R, Python, and SAS
• Emphasize open-source adoption, automation, and appropriate use of AI
• Address operational challenges through strategic standard-based solutions
• Facilitate global adoption of standards and programming best practices
• Contribute strategic solutions for cross-functional stakeholder groups in BARDS, GCD, and the Research & Development Division
• Provide technical consultation and analytical support to statistical programmers and statisticians
• Lead and contribute to departmental strategic initiative project teams
• Represent the company in industry initiatives including CDISC and PHUSE
• Collaborate with Biostatistics, Statistical Programming, Data Management, Clinical Research, Regulatory, Observational Research, Clinical Safety, and PK/PD Modeling and Simulation organizations
• Drive analysis and reporting data structures and submission standards
• Adhere to departmental standard operating procedures and guidelines

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or related field plus 12 or more years of statistical programming experience in a clinical trial environment, or MS in a related field plus 10 or more years of such experience
• Excellent interpersonal, negotiation, and collaboration skills
• Excellent written, oral, and presentation skills
• Superior knowledge and significant experience setting strategy and developing analysis and reporting deliverables for R&D projects
• Excellent project management skills and leadership across multiple complex programs
• Ability to determine approaches, ensure consistency, direct development of others, and engage key stakeholders
• Expertise in clinical trial programming, including data manipulation, reporting workflows, visualization, and production-quality practices using multiple programming languages and tools
• Superior knowledge and significant experience developing statistical programming deliverables according to quality, compliance, and timeliness requirements
• Strong knowledge and understanding of CDISC SDTM and ADaM analysis dataset standards
• Experience with analytical research databases, analysis datasets, and procedures
• Understanding of statistics, clinical trials, and data management concepts applied to drug and vaccine development
• Demonstrated success assuring deliverable quality and process compliance
• Strategic thinking and ability to develop and implement strategic solutions
• Ability to anticipate stakeholder requirements
• Ability and interest to work across cultures and geographies
• Preferred: experience developing multilingual analysis and reporting products using R, Python, and SAS
• Preferred: process assessment, improvement, and operational excellence methodologies
• Preferred: experience developing and managing project plans
• Preferred: experience using AI/GenAI tools such as Claude Code
• Preferred: active participation in professional societies and collaboration across regions
• Required skills include Clinical SAS Programming, Data Management, Data Modeling, Numerical Analysis, R Programming, and Stakeholder Relationship Management
• Visa sponsorship available
• Travel requirements: 10%
• Valid driving license: not required

Demonstrates expertise in statistical programming and analysis for clinical trials, with a strong focus on R, Python, and SAS. Proven ability to develop and implement strategic solutions while ensuring compliance with industry standards such as CDISC.

• Clinical SAS Programming
• Data Management
• R Programming
• Statistical Programming Deliverables
• Stakeholder Relationship Management

• Statistical Programming
• Data Manipulation
• Reporting Workflows
• Visualization
• Numerical Analysis
• Multilingual Analysis Development
• Quality Compliance
• Analysis Dataset Standards
• Process Improvement
• AI/GenAI Tools

• Interpersonal Skills
• Negotiation Skills
• Collaboration Skills
• Project Management Skills
• Strategic Thinking

• Clinical Trials
• Drug Development
• Vaccine Development
• CDISC
• PHUSE
• Biostatistics
• Regulatory Compliance
• Observational Research
• PK/PD Modeling
• Statistical Analysis