[Hiring] Research Scientist - Statistics @Elanco

Role Description

The Research Scientist - Statistics provides critical statistical leadership and support for Research and Development (R&D) studies, facilitating the global registration of innovative animal health products. This role is instrumental in the lifecycle of product development, ensuring statistical integrity from initial protocol design through to final regulatory submission. Additionally, individuals in this position may also support initiatives working with or supporting EKS, Marketing, Technical Development and other strategic areas.

Key Responsibilities

• Core Statistical Support
  • Study Design & Planning: Contribute to or co-author study protocols by providing expert statistical input on experimental design, randomization, sample size calculations, and methodology.
  • Analysis & Execution: Perform statistical analysis of data in strict adherence to study protocols. Deliver high-quality results in standard formats, including Statistics Reports, and Tables, Figures, and Listings (TFLs).
  • Reporting: Contribute to the authoring and review of comprehensive study reports for regulatory submission and manuscripts for publication.
  • Timelines: Manage statistical deliverables to ensure alignment with established project timelines and priorities.
• Innovation & Advanced Methodologies
  • New Concepts: Actively investigate and implement statistical methods, specifically focusing on:
    • Artificial Intelligence (AI): Exploring machine learning and LLM applications utilizing study and Real World data.
    • Digital Twins: Developing and maintaining digital twins for predictive modeling in animal health.
    • Bayesian Initiatives: Applying Bayesian frameworks to enhance decision-making and trial efficiency.
    • Adaptive Designs: Integrating flexible trial frameworks such as interim analyses and sample size re-estimation to improve study flexibility while maintaining strict regulatory compliance.
  • Continuous Improvement: Contribute to the development, dissemination and implementation of novel statistical methods and best practices within the Statistics team.
• Regulatory & Compliance
  • Quality Standards: Ensure all work complies with regional and local regulatory requirements, including GLP, GCP, EMA, FDA, and USDA standards.
  • Functional Procedures: Assist in the development and periodic review of Elanco Functional Procedures and standard operating practices.
  • Functional Processes: Assure all work complies with Elanco Functional Procedures and business processes.
• Collaboration & Strategic Support
  • Cross-Functional Partnership: Routinely collaborate with colleagues in Clinical Development, Regulatory Affairs, Data Management, Quality Assurance, and Marketing.
  • External Management: Oversee Contract Research Organization timelines and perform technical reviews of their deliverables.
  • Strategic Initiatives: Support strategic R&D initiatives within Elanco Clinical Sciences and with cross-functional teams.

Qualifications

• Education: PhD or MSc/MS in Statistics, Biostatistics, or a strongly related field.
• Core Training: Demonstrated training in Design of Experiments (DoE), GLMM, Survival Analysis, and Categorical Methods. Demonstrable exposure to applications and training in the AI/ML domain.
• Technical Proficiency: Advanced experience using Python, R, and/or SAS software. Demonstrated capability with statistical application of AI-related tools.

Requirements

• Programming: Proficient in multiple programming languages used in industry statistical applications.
• Regulatory Experience: Familiarity with licensing animal health products in the US or Europe.
• Software: Expert user of Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Benefits

• Multiple relocation packages
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching