Scientist-Bioinformatics

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 35,000 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.

The Laboratory for Experimental Medicine (LEM) Scientific Implementation Group (SIG) leads all aspects of outsourced immunogenicity and related biomarker assays in support of clinical studies. This role, in collaboration with LEM clinicians and scientists, will provide support for ongoing projects to ensure the accuracy of data outputs. Our team performs data analysis to verify that results are consistent with previous study results and expected tables, figures, and legends (TFLs) as well as data visualization through a previously developed internal IT system in LEM. We provide consultative support to the Product Team, Clinical Lab Services (CLS) associates, and Third Party Organizations (TPO)s. In addition to the support of projects, this role will provide operational support for tracking LEM reagents, as well as other operational and quality-related tasks, and will be encouraged to improve and/or perform internal processes currently completed by the SIG scientists and Operations consultants.

Do you have computer programming experience which enables efficient analysis of large data files and data visualization using R or other similar platform? Your skills might be a match for this role. Check this out and apply today! We're looking forward to having you on Team Lilly!

LEM SIG Key Responsibilities:

• Work with SIG scientists and clinicians to generate summarized ADA results from an internally developed web-based tool aimed at analyzing clinical study data from multiple sources to quickly provide top-level summaries of results.
• Identify any issues with data format or integrity from the input files to the web-based tool to ensure that all results are accurately transferred from TPOs to central lab. Perform sample reconciliation using cumulative data files from the TPOs and internal systems.
• Provide basic statistical support to high-priority LEM projects with Discovery Stats, clinicians and SIG scientists.
• Work as a team to provide scientific oversight activities for work relating to a TPO in a GMP-like environment.

Responsibilities may include:

• Stay current on new TPO technologies/capabilities as well as ongoing performance to manage enterprise risk and make recommendations for optimal study support to LEM, CLS, and the study team,
• Lead the group in trouble-shooting data integrity issues with the TPO,
• Accountable for understanding and applying new processes to improve data management from TPOs.
• Partner with the LEM clinicians to build visualization of ADA results with pharmacodynamic (PD) endpoints from LEM exploratory biomarkers or pharmacokinetic (PK) data.
• Work with SIG scientists responsible for Levy Jennings to update files and outputs for monthly assay monitoring meetings as well as monitoring overall vendor performance
• Update, maintain, and improve current internal electronic SIG reagent inventory.
• Maintain and improve the structure of internal collaboration sites like MSTeams and Sharepoint
• Collaborate with the SIG scientist to update ADA validation plan and report templates Lead constant process improvements through the use of tools/apps/automation.

Basic Requirements

B.S. or M.S. with a background in biology and/or bioinformatics.

Additional Preferences

• Proven leadership and organizational skills
• Excellent oral and written communication skills
• Ability to influence and mentor other individuals; strong relationship skills
• Excellent experimental design skills; scientific approach to problem solving; method development, validation and sample analyses
• Experience in molecular biology, analytical diagnostic techniques, cellular immunology assays, binding assays, and/or immunohistochemistry
• Experience in a regulated/quality (e.g. GLP, GCP, GMP, etc.) environment, specifically related to immunogenicity and biomarkers.
• Familiarity with the structure of data files from clinical trails
• Knowledge of immunogenicity assays and data structure of results
• Previous work experience in LEM, CLS, or both
• Operations (financial, management, etc.)

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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.