Advisor - Project Statistician in Product Development

BioSpace; Indianapolis (IN); On-site; USD 153,000 - 246,000; Full time

Benefits offered by this job

Company bonus

Comprehensive benefits

401(k)

Job summary

Lilly Research Laboratories is seeking a highly qualified statistician to support product development in Indianapolis. You will provide statistical leadership across projects, collaborate with biologists, chemists, formulators, and engineers, and advance novel methods for drug development.

The role emphasizes experimental design, analysis, and regulatory submission support, with a focus on learning and communicating complex concepts to diverse scientists.

Qualifications

• Ph.D. or MS with extensive statistics experience.
• Strong English communication of technical issues.
• Proficient in R, Python, JMP and/or SAS.
• DOE, Bayesian methods, machine learning, and data visualization.
• Interpersonal/teamwork and leadership skills.

Responsibilities

• Provide statistical support to scientists in product development across modalities.
• Design experiments and analyze data for chemists, biologists, and formulation scientists.
• Design and analyze long-term and accelerated stability studies for clinical specs.
• Develop novel statistical methods to enable drug development and manufacturing.
• Collaborate with scientists and statisticians and present results clearly.

Skills

DOE

Bayesian

Machine learning

Visualization

Statistical analysis

Communication

Education

Ph.D. in Statistics/related field

M.S. in Statistics/related field (8+ years)

Tools

R

Python

JMP

SAS

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Brand Description

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.

Communication

• 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

• Ph.D. in Statistics, Biostatistics, Industrial Engineering, Operations Research, or related field or M.S. in Statistics, Biostatistics, Industrial Engineering, Operations Research, or related field with at least 8 years relevant 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
• Demonstrated problem solving ability and strategic thinking
• Degree in or strong desire to learn about chemistry, biology, engineering, computer science, and pharmaceutical science

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $153,000 - $246,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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