Associate Manager - Biostatistician chez Elanco

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Position Description:

The role of Biostatistician is to support the biostatistics and statistical analysis in terms of analysis dataset creation, statistical analysis and creation of statistical analysis tables and summaries in collaboration with statistical and programming colleagues, physicians, veterinarians, and/or medical colleagues.

Functions, Duties, Tasks:

• Prepare statistical analysis plans, including table under the supervision of senior statistical staff.
• Use SAS or other software to develop custom programming code to generate tables, data listings, graphs and derived datasets as specified in the protocol/statistical analysis plan.
• Generate randomization schedules from provided specifications under guidance from senior statistical staff.
• With mentoring, provide sample size calculations and review protocols for completeness and appropriateness of statistical sections.
• Ensure that outputs meet quality standards and project requirements.
• Perform validation programming and work with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
• Keep project team members informed of programming progress and issues requiring their attention.
• Follow applicable SOPs and relevant regulatory guidelines.
• Manage scheduling and time constraints across multiple projects at a time, set goals based on priorities from management, and adapt to timeline or priority changes by reorganizing daily workload.
• Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for opinions of others.
• Display willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
• Negotiate and establish accurate time estimates for completion of study activities with internal team members and statistical management, and complete project activities within timeframe allotted.
• Assist in drafting regulatory submissions.
• Effectively utilize current technologies and available tools for conducting the analyses.
• Keeping up-to-date with current literature and research new methodologies.
• Ensure scientific integrity and animal welfare in all activities.
• Interact with global statisticians and implement recommendations locally.
• Create and maintain standard macros and applications to improve the efficiency of the department.
• Proactively participate in and/or lead process/quality improvement initiatives, standardization, and other non-clinical initiatives.
• Engage in knowledge share activities.

Minimum Qualification (education, experience and/or training, required certifications):

• MSc in statistical discipline (Statistics, Biostatistics or related)
• Minimum 4 years of relevant experience (some vaccine development experience will be a plus)
• Fundamental understanding of basic statistical procedures.
• Proficiency in SAS programming with associated basic and advance certifications.
• Knowledge of R programming desirable
• Strong GxP knowledge, in particular GLP, GCP and GMP.
• Good written and verbal communication skills
• Knowledge of animal health is considered a plus.

Additional Preferences:

• In-depth knowledge of GxP requirements and regulatory guidelines.
• Ability to solve complex problems.
• Sound understanding of operational Regulatory and R&D principles.
• Ability to communicate logically and technically.
• Organizational planning skills, ability to manage competing priorities and flexibility to change.
• Commitment to quality.
• Ability to work independently or as part of a team.
• High competency in Microsoft Office.
• Ability to work additional hours as required and work with staff in irregular time zones.
• Ability to learn new systems and functions in an evolving technical environment.

Other Information:

• You will be part of the Global Operations team.
• You will work with groups in the USA, Australia, and EU region.
• You will manage Elanco operational requirements locally and ensure implementation of policies and procedures.
• You will be required to indirectly manage stakeholders that are on global scientific teams.
• You will be part of project teams as 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