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As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
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.
- 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.
- MS or MSc in Statistics or Biostatistics or strongly related field with training in Design of Experiments, GLMM, Survival and Categorical Methods.
- Experience using SAS software
- PhD in Statistics or Biostatistics or strongly related field with training in Design of Experiments, GLMM, Survival and Categorical Methods.
- Experience using Microsoft products Word, Excel, PowerPoint and Outlook. R programming capabilities. Experience in licensing animal health products in the US or Europe.
- Experience with CRO's
- Experience in a regulated environment
- Travel: up to 10%
Notification of Drug testing and Background Checks
Elanco conducts urinalysis drug testing as a mandatory part of its pre-employment application and background check process after acceptance of a conditional offer of employment by an applicant. The drug testing will be conducted by a certified laboratory/testing service selected by Elanco, in accordance with the procedures required by applicable state and federal law. Additionally, Elanco requires successful completion of a urinalysis drug test if it has reasonable suspicion that an employee is under the influence of drugs or alcohol which adversely affects or could adversely affect the employee's job performance as allowed by applicable law. Tested applicants will be given a copy of any positive test result. All test results shall be considered confidential and shall not be disclosed by Elanco, other than to those persons for whom such disclosure is necessary. Positive test results, or a refusal to consent to and participate in pre-employment drug testing, shall be grounds for denial of employment. Cooperation in scheduling the testing is important for processing an application for employment. By signing your acceptance to an offer of employment, you consent to be drug tested and acknowledge you have thoroughly read the foregoing notice and policy, and you understand and agree that in order to be considered for employment with Elanco, you will be required to comply with Elanco's drug testing policy. Elanco's background check requirements also include but are not limited to an acceptable criminal background check, educational verification, job history verification and motor vehicle report (if required to drive a company vehicle). If appropriate for the role, as outlined on the job posting, successful completion of Post Offer Exam, Work Simulation and/or Administrative Skills Testing may also be required.
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