Statistician, M&Q at 706 Elanco US Inc. in greenfield, Indiana

Job Description:

Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? Search our job listings below.

(This position may be located in Greenfield, IN, Ft. Dodge, IA or other internal Elanco sites)

Position Brand Description:

Reporting to the Senior Director of TSMS Vaccines Network, the Statistician role is responsible for providing in-depth statistical support to Technical Services and Quality teams based at hubs, manufacturing sites, and associated laboratories.  The Statistician will also work in close collaboration with the other TSMS statistician to drive statistics excellence within the M&Q function.

The role will support the construction of control strategies for current/new products and processes, driving and sustained statistical thinking and appropriate use of statistical methodologies with emphasis on biologicals/natural products. 

Specific aspects include (but are not limited to) statistically designed experiments, sampling, stability, packaging, establishment of regulatory specifications, evaluation of control/capability, and process/analytical method validation/transfers.  The role will also reach across networks to develop statistical capabilities at sites and provide Statistical training.

Key Objectives/Deliverables

Provide statistical expertise, study design, and analysis and communicate data driven decisions for process improvements, process understanding, method development and validation, assay transfer, and stability studies in collaboration with personnel supporting all aspects of manufacturing. Establish control strategies for manufacturing processes and analytical assays, evaluate process control and capability, and determine appropriate regulatory and release specifications. Maintain statistical expertise by learning new methodologies, choosing which methods to use in analysis, and justifying methods selected. Communicate study results and statistical concepts in one-on-one meetings, oral presentations, internal reports, and presentations at professional association meetings. Develop and administer training courses for various statistical methods and software, including planning and leading workshops to help facilitate statistical thinking across the various functional areas. Develop site expertise in appropriate and useful statistical methods by mentoring, coaching, and technical oversight. Participate in root cause analysis investigations to drive resolution of supply issues. Serve as the statistical lead and effective member of cross functional teams.  Work in a highly fluid environment with rapidly changing priorities providing statistical guidance and problem-solving acumen to diverse teams.

Basic Requirements:

Excellent problem solving skills. Strong interpersonal skills (job requires significant customer/peer/management interaction). Excellent verbal and written communication skills. Ability to participate in and facilitate decision-making. Proficiency in the use of statistical software (eg: JMP, SAS, etc.)

Additional Preferences:

Experience with preparation of regulatory documents such as Briefing Documents, CTD content, and responses to questions from regulatory agencies. Coursework in Experimental Design, Regression, Statistical Process Control, Mixed Models, Bioassay, Sampling). Relevant industry experience (animal health, pharmaceutical manufacturing, analytical laboratories, process development) Proven technical leadership capability (site leadership or project based) Effective communication in multi-cultural settings Ability to influence people Ability to build collaborative relationships with areas inside and outside of Elanco Experience in R&D development processes

Education Requirements:

Minimum of a MS in Statistics

Other Information:

Shift: Monday–Friday, flex time observed

Location: Greenfield, IN, Ft. Dodge, IA or other internal ELANCO sites

Benefits include relocation assistance

Travel Requirements: 10% approx.

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