Statistician in Product DevelopmentInitial Therapeutics, Inc. • Indianapolis, IN, US

Statistician in Product Development

Initial Therapeutics, Inc. • Indianapolis, IN, US

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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 relentless 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.

Location

Indianapolis

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 inform 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 :

M.S. in Statistics, Biostatistics, Industrial Engineering, or Operations Research.

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.

Demonstrated exemplary teamwork / interpersonal skills.

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

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

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Statistician • Indianapolis, IN, US