Principal Scientist, Statistical Programming – A&R Standards, Innovation

Responsibilities

• Support 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 that include analysis and reporting data standards and submission standards.
• Actively leads and contributes to the department's strategic initiatives.
• 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.
• 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.
• Provide technical consultation and analytical support to statistical programmers and statisticians.
• Lead and actively contribute to departmental strategic initiative project teams.

• 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
• 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.
• Expertise in clinical trial programming, including data manipulation, reporting workflows, visualization, and production-quality practices using multiple programming languages and tools.
• Strong knowledge and understanding of CDISC SDTM and ADaM analysis dataset standards.
• Demonstrated understanding of statistics, clinical trial, and data management concepts as applied to drug/vaccine development.
• Strategic thinking - ability to analyze operational activities and challenges and develop and implement strategic solutions.
• Ability and interest to work across cultures and geographies.

• statistical programming
• data manipulation
• reporting workflows
• visualization
• production-quality practices
• R
• Python
• SAS
• CDISC SDTM
• ADaM

• interpersonal skills
• negotiation
• collaboration
• written communication
• oral communication
• presentation skills
• project management
• leadership
• strategic thinking
• cross-cultural communication

• BA/BS in Computer Science
• MS in Computer Science