Product Development Statistician

Indianapolis, IN, United States

Job Details

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Lilly Research Laboratories (LRL) aims to discover and develop novel medicines that will benefit patients globally through a steadfast focus on innovation and solutions to unmet needs. We are looking for a highly qualified statistician to support a wide variety of projects in the product development (nonclinical) area of LRL in collaboration with biologists, chemists, formulators, and engineers. In addition to strong technical skills, the role requires a strong desire and ability to take initiative, educate, and communicate the value of good statistical practices and concepts to a variety of fellow scientists.

Key Objectives/Deliverables:

The statistician will provide statistical support to scientists in Product Development with a mix of emphasis on a variety of molecule types, including new modalities.

Experimental design and analysis support for chemists/biologists and formulation scientists to develop & optimize chemical/biochemical processes as well as oral and parenteral formulations, in both batch and continuous manufacturing

Experimental design and analysis support for analytical chemists to develop, validate, and transfer analytical methods

Design and analysis of long-term and accelerated stability studies to advise development of clinical phase and commercial specifications and expiry dating

Development and implementation of novel methods to enable or advance drug development and manufacturing

Author sections of CMC (Chemistry, Manufacturing, and Controls) regulatory submission documents for successful product approval throughout the world

Collaborate with scientists and statisticians on applied research projects related to modeling, experimental design, process control, and/or multivariate analysis.

Communicate Results Collaborate with team members or external partners to communicate development study results with an emphasis on clarity and visualization

Assist with or be responsible for communicating via manuscript or oral presentation

Communicate results in one-on-one meetings with key customers or external partners and present at scientific meetings

Therapeutic/Scientific Area Knowledge Develop understanding of scientific areas and disease states to enhance the level of customer focus and collaboration and be a strong scientific contributor.

Regulatory Compliance Perform work in full compliance with assigned curricula and follow applicable Corporate, local, and departmental policies, procedures, processes, and training.

Training and Development Develop and provide training courses for various statistical methods

Requirements: PhD in Statistics, Biostatistics, Industrial Engineering, Operations Research, or related field with at least 5 years pharmaceutical experience

or

M.S. in Statistics, Biostatistics, Industrial Engineering, Operations Research, or related field with at least 10 years pharmaceutical experience

Additional Skills/Preferences: Additional work experience, especially in the application of statistics in the pharmaceutical development or manufacturing areas

Excellent English communication skills, especially related to technical/scientific issues

Proficient in R, Python, JMP and/or SAS programming language.

Proficient in acquiring and compiling data across sources

Expertise in DOE, Bayesian, machine learning, visualization

Interpersonal/teamwork and communications skills for effective customer collaboration

Strong teamwork and leadership skills

Self-management skills, creativity, and innovation

Degree in or strong desire to learn about chemistry, biology, engineering, computer science, and pharmaceutical science

Ability to balance multiple activities, prioritize and manage ambiguity

Demonstrated exemplary teamwork/interpersonal skills

Demonstrated problem solving, critical thinking, attention to detail and result oriented behaviors in a fast-paced environment.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly