Senior Principal Scientist, Biostatistics Full-time

Senior Principal Biostatistician, Methodology Research

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

• Contributes to the development, validation, deployment, and maintenance of statistical computing solutions that enable rigorous, reproducible, and efficient use of advanced methodology.
• Provides strategic scientific leadership, originates and develops new methodology ideas.
• Publishes relevant statistical methodology in peer reviewed journals and presents at professional meetings; contributes influential publications, software, tutorials, or other public scientific resources that advance statistical practice inside and outside the company.
• Consults with clinical trial teams and other functional areas to implement advanced design and analysis including implementation through fit-for-purpose R packages, Shiny applications, web-based interfaces, and other validated computing tools.
• Partners with BARDS teams to design, develop, and deploy automation of workflows; works highly collaboratively across teams to deliver reliable, compliant solutions.
• Interacts with contractors, providing technical direction, review, and coaching for software development practices used by internal and external contributors.
• Collaborates on internal standards development, strategic initiatives and training.
• Maintains external relations and contributes to relevant professional activities/associations through leadership in statistical computing, open-source scientific software, interactive graphics, reproducible reporting, and related professional communities.

Primary Activities

• Independently identifies, anticipates and responds to technical and strategic problems arising in the design, conduct, and analysis of clinical trials; proposes solutions and carries them out or consults to enable others to implement.
• Independently evaluates the appropriateness, reliability, and maintainability of available software for planned analyses and interactive applications; identifies needs for new or improved software; and leads or co-leads development in R and other relevant languages and technologies.
• Independently applies and implements advanced analytical methods to design and analysis of clinical trials and ensures that implementation is transparent, tested, documented, reproducible, and sustainable for broader BARDS use.
• Prepares oral and written reports to effectively communicate results of advanced methods to project teams, strategic initiatives, our company's Management, or regulatory agencies including dynamic reports, interactive visualizations, and web applications when these improve communication or decision making.
• Leads documentation, testing, code review, version control, and maintenance practices that make statistical methodology reproducible, auditable, well documented, and reusable; coaches others in these practices across project teams and methodological initiatives.
• Provides responses to queries relating to advanced methodology posed by clinical researchers, regulatory agencies, and/or investigators including questions on software implementation, reproducibility, simulation, and computational performance when relevant.
• Collaborates in publication of research results and, where appropriate, develops accompanying reproducible examples, software packages, vignettes, tutorials, or interactive demonstrations to increase scientific impact and adoption.
• Mentors and guides junior staff in research and functional activities including statistical software development, package architecture, code quality, testing, and documentation.
• Evaluates and applies artificial intelligence, large language models, and other emerging technologies to accelerate automation of workflows while maintaining scientific rigor and regulatory compliance.
• Participates in departmental activities; leads training and contributes to communities of practice that raise BARDS capability in statistical computing, reproducible reporting, and collaborative software engineering.

Education and Minimum Requirement

• PhD or equivalent degree in statistics/biostatistics statistical computing, data science or related discipline with a minimum of 9 years relevant work experience, or a Master's degree with a minimum of 12 years relevant work experience.

Required Skills and Experience

• Solid knowledge of statistical analysis methodologies and experimental design.
• Strong scientific leadership in design and analysis of clinical trials and/or other areas of interest for pharmaceutical drug development.
• Strong project management skills with ability to lead cross-functional methodological and software initiatives from concept through adoption and maintenance.
• Advanced capability in statistical computing, with particular expertise in R and demonstrated ability to use or lead development in other relevant languages and technologies such as Python, JavaScript, C++, HTML/CSS, SQL, Git/GitHub, R Markdown/Quarto, and Shiny.
• Demonstrated experience designing, developing, testing, and maintaining R packages or comparable statistical software for a broad user community.
• Demonstrated expertise in interactive methods such as Shiny applications, dynamic reporting, interactive visualization, or web-based decision-support tools.
• Ability to work highly collaboratively on automation and other cross-cutting initiatives, with a track record of building productive working relationships.
• Solid understanding of worldwide regulatory requirements and clinical trial expertise; familiarity with clinical reporting and regulatory submissions workflows.
• Excellent oral and written communication skills and strong leadership in a team environment with ability to teach, influence, and establish good computing practices across statisticians, programmers, scientists, and contractors.
• Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development including robust computational implementation of those methods.
• Publications in peer reviewed statistical/medical journals or other important contributions to the literature and scientific computing community, such as books, software papers, widely used packages, reproducible research resources, or invited tutorials.
• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

Preferred Skills and Experience

• Recognized as an expert in the quantitative sciences within the company and externally with a strong reputation within the biopharmaceutical sciences or in statistical computing communities that materially advance biopharmaceutical quantitative science.
• Knowledge of statistical methods in emerging areas (e.g., machine learning, complex adaptive trial design, causal inference) as well as applications in related to other relevant areas (e.g., reimbursement, safety, real world evidence, epidemiology).
• Experience reviewing, simplifying, refactoring, and improving code for readability, performance, maintainability, and long-term ownership by scientific teams.
• Record of training, mentoring, or establishing team practices for package development, open-source-style collaboration, code review, automated testing, documentation, and reproducible workflows.
• Practical experience with artificial intelligence and large language models applied to coding, document generation, review, or other operational tasks in pharmaceutical development.
• Experience with both R and Python for clinical reporting, regulatory submission, and automation of standard workflows.