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 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 #J-18808-Ljbffr Jobtailor