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Position Description: 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 closely with the Senior Director and senior staff on the Statistics and Clinical Analytics Team.
Functions, Duties, Tasks:
- Contribute to or co-author the writing of study protocols, providing statistics input for experimental design, primary and secondary outcomes, randomization, sample size, statistics methodology and data collection sections.
- Provide statistical analysis of data following the statistical methodology outlined in the study protocol. Deliver statistics results in an agreed upon format (eg, Statistics Report or Table, Figures and Listings).
- Contribute to or co-author the writing of study reports.
- Deliver statistics deliverables in accordance with established timelines and priorities.
- 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 participate and contribute to the development and implementation of new statistical methods, 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.
- Manage CRO timelines and review deliverables.
- Provide CMC project statistics support as assigned.
- Participate in 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 training in DoE, GLMM, Survival and Categorical Methods. BS in Statistics or Data Analytics with DoE, GLMM, Survival and Categorical Methods training and experience in life sciences.
- Experience using SAS software.
- Experience using Microsoft products Word, Excel, Powerpoint and Outlook. R programming capabilities.
- Experience in licensing animal health products in the US or Europe.
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