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 ResponsibilitiesCore 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.
QualificationsMinimum Requirements- 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.
Additional Preferences- Programming: Proficient in multiple programming languages usedin 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).
Behavioral Competencies- Entrepreneurial Mindset: Ability to work in a fast-paced, collaborative environment with a focus on innovation and problem solving.
- Communication: Strong verbal and written communication skills to effectively translate complex statistics for non-statistical project team members.
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
- 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
