Principal Scientist, Stat. Programming – A&R Standards, Innovation (Hybrid) Full-time

Biostatistics And Research Decision Sciences Quantitative Scientist

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

Responsibilities:

This position supports the strategic design, development, and delivery of efficient, flexible, and modular analysis and reporting and submission standards and tools that can be used for drug and/or vaccine projects across all therapeutic areas. Adheres to standard operating procedures and guidelines established by the department. Drives data structures which include analysis and reporting data standards and submission standards. Actively leads and contributes to the department's strategic initiatives.

The position is a key collaborator with internal and external stakeholders including Biostatistics, Statistical Programming, Data Management, Clinical Research, Regulatory, Observational Research, Clinical Safety, and PK/PD Modeling and Simulation organizations.

Primary Activities:

• Drive the development and adoption of scalable, reusable multilingual standards library based on R, Python and SAS with an emphasis on open-source adoption and automation, leveraging AI where appropriate.
• Address operational challenges that require strategic standard-based solutions, resulting in improved analysis and reporting deliverables.
• Facilitate global adoption of standards and programming best practices.
• Contribute to strategic solutions in support of cross functional stakeholder groups in BARDS, GCD, and our Research & Development Division.
• Provide technical consultation and analytical support to statistical programmers and statisticians.
• Lead and actively contribute to departmental strategic initiative project teams.
• Represent our Company on relevant industry initiatives including CDISC and PHUSE.

Skills:

Education and Minimum Requirement:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 12 or more years statistical programming experience in a clinical trial environment OR
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 10 or more years statistical programming experience in a clinical trial environment

Department Required Skills and Experience:

• Excellent interpersonal skills and ability to negotiate and collaborate effectively.
• Excellent written, oral, and presentation skills.
• Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Excellent project management skills; leadership across multiple and complex programs; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders.

Position Specific Required Skills and Experience:

• 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 in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) according to quality, compliance and timeliness requirements.
• Strong knowledge and understanding of CDISC SDTM and ADaM analysis dataset standards.
• Experience working with analytical research databases including various analysis datasets and procedures.
• Demonstrated understanding of statistics, clinical trial, and data management concepts as applied to drug/vaccine development.
• Demonstrated success in the assurance of deliverable quality and process compliance.
• Strategic thinking – ability to analyze operational activities and challenges and develop and implement strategic solutions.
• Ability to anticipate stakeholder requirements.
• Ability and interest to work across cultures and geographies.

Preferred Skills and Experience:

• Experience developing flexible and efficient multilingual products for analysis and reporting using R, Python, SAS.
• Experience with process assessment, improvement and operational excellence methodologies.
• Experience developing and managing project plans.
• Experience using AI/GenAI tools, such as Claude Code, to enhance coding, automation, and workflow efficiency.
• Active in professional societies and ability to collaborate across regions.