- 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
Requirements
- 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
Core Competencies
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.
Highest-signal resume keywords
- Clinical SAS Programming
- Data Management
- R Programming
- Statistical Programming Deliverables
- Stakeholder Relationship Management
ATS Optimization Keywords
Hard Skills
- Statistical Programming
- Data Manipulation
- Reporting Workflows
- Visualization
- Numerical Analysis
- Multilingual Analysis Development
- Quality Compliance
- Analysis Dataset Standards
- Process Improvement
- AI/GenAI Tools
Soft Skills
- Interpersonal Skills
- Negotiation Skills
- Collaboration Skills
- Project Management Skills
- Strategic Thinking
Industry Keywords
- Clinical Trials
- Drug Development
- Vaccine Development
- CDISC
- PHUSE
- Biostatistics
- Regulatory Compliance
- Observational Research
- PK/PD Modeling
- Statistical Analysis