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This position provides statistical support for research and development studies supporting global registration of animal health products. This role contributes to the development of new products by providing statistical support for protocol development, statistical analysis plans, sample size calculations, randomizations, statistical analyses and reporting thereof and provides input into clinical reports for pilot and pivotal studies in compliance with internal operating procedures and global regulatory standards and guidelines.
Additionally, individuals in this position may also support company initiatives, execution of clinical analytics strategy, and statistical support for CMC projects. Individuals in this position routinely collaborate with colleagues in regulatory affairs, data management, quality assurance, and product development. Individuals in this position work under the direction of the Senior Director but have responsibility for managing and meeting project timelines. Individuals in this position are recognized for their statistical expertise in one or more animal species and area of research (Vaccines, Parasiticides, Therapeutics). Individuals in this position represent the company’s interests and statistics function in meetings with regulators. Additionally, they oversee and manage external statistics support for projects.
Functions, Duties, Tasks:
- Contribute to or co-author the writing of study protocols. Lead statistical support and complete protocol sections for experimental design, primary and secondary outcomes, randomization, sample size, statistics methodology. Provide input for data collection activities.
- Provide randomization schedules and sample size estimates.
- Provide statistical analysis of data following the statistical methodology outlined in the study protocol. Identify necessary statistics deliverables and deliver in an agreed upon format (eg, Statistics Report or Table, Figures and Listings).
- Contribute to or co-author the writing of study reports.
- Work with project teams to establish and manage timelines for statistics deliverables. Meet associated timelines.
- Collaborate with data management and clinical team members to ensure data is provided in an appropriate format.
- Contribute to manuscripts, regulatory submissions and responses and additional project team requests.
- Assist in the development and review of Elanco Functional Procedures and Practices documents.
- Actively contribute to and may lead the development and implementation of new statistical methods, study designs, statistics team processes, and the Statistics Community of Practice.
- Work in compliance with regional and local regulatory requirements including GLP, GCP, EMA, FDA and USDA requirements.
- Actively contribute to interpretation of regulatory guidance for project teams, lead interpretation regarding aspects of a statistics nature. Provide clarity and transparency to scientists in the application and interpretation of statistics methods through effective presentations and communication.
- Represent the statistics function in project team meetings with regulators. Manage CRO timelines and review deliverables.
- Meet as needed with the Senior Director to resolve project issues and assure effective prioritization.
- Provide CMC project statistics support as assigned.
- Participate in and promote a collaborative environment with an entrepreneurial mindset. Effectively communicate with project team members.
Minimum Qualification (education, experience and/or training, required certifications):
PhD, MSc or MS in Statistics or Biostatistics or strongly related field with demonstrated success in licensing animal health products in the US or Europe. Competent programmer using SAS software.
Machine learning and AI knowledge. Experience using Microsoft products Word, Excel, Powerpoint and Outlook. R programming capabilities.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status