Cmc Statistician Jobs in Indiana (NOW HIRING)

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.

Organizational & Position Overview:

TheBioproductResearch&Development(BR&D)organizationstrivestodelivercreative medicines topatients by developing and commercializing insulins, monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies, and gene therapy systems. This multidisciplinary group works collaboratively with our discovery and manufacturing colleagues.

We are seeking an exceptional Data Scientist with deep data expertise in the pharmaceutical domain to lead the development and delivery of enterprise-scale data products that power AI-driven insights, process optimization, and regulatory compliance. In this role, you'll bridge pharmaceutical sciences with modern data engineering to transform complex CMC, PAT, and analytical data into strategic assets that accelerate drug development and manufacturing excellence.

Responsibilities:

Data Product Development:Define the roadmap and deliver analysis-ready and AI-ready data products that enable AI/ML applications, PAT systems, near-time analytical testing, and process intelligence across CMC workflows.

Data Archetypes & Modern Data Management: Define pharmaceutical-specific data archetypes (process, analytical, quality, CMC submission) and create reusable data models aligned with industry standards (ISA-88, ISA-95, CDISC, eCTD).

Modern Data Management for Regulated Environments: Implement data frameworks that ensure 21 CFR Part 11, ALCOA+, and data integrity compliance, while enabling scientific innovation and self-service access.

AI/ML-ready Data Products: Build training datasets for lab automation, process optimization, and predictive CQA models, and support generative AI applications for knowledge management and regulatory Q&A.

Cross-Functional Leadership:Collaborate with analytical R&D, process development, manufacturing science, quality, and regulatory affairs to standardize data products.

Deliverables include:

• Scalable data integration platform that automates compilation oftechnical-review-readyandsubmission-readydata packages with demonstrable quality assurance.

• Unified CMC data repository supporting current process and analytical method development while enabling future AI/ML applications across R&D and manufacturing

• Data flow frameworks that enable self-service access while maintaining GxP compliance and audit readiness

• Comprehensive documentation, standards, and training programs that democratize data access and accelerate product development

Basic Requirements:

• PhD in Computer Science, Data Science, Machine Learning, Biomedical / Medical Informatics, Computational Biology, AI, or closely related STEM degree and 0-5 years of pharmaceutical industry experience; or

• Master of Science in Computer Science, Data Science, Machine Learning, AI, Computational Biology, Biostatistics / Applied Statistics / Statistics, or closely related STEM degree and 5+ years of pharmaceutical industry experience.

• Knowledge of modern data stack technologies(Microsoft Fabric, Databricks, Airflow) and cloud platforms (AWS- S3, RDS, Lambda/Glue, Azure).

• Demonstrated experience designing data products that support AI/ML workflows and advanced analytics in scientific domains.

• Proficiency with SQL, Python, and data visualization tools.

• Experience withanalytical instrumentation and data systems(HPLC/UPLC, spectroscopy, particle characterization, process sensors).

• Knowledge ofpharmaceutical manufacturing processes,including batch and continuous manufacturing, unit operations, and process control.

• Expertise with data modeling for time-series, spectroscopic, chromatographic, and hierarchical batch/lot data.

• Experience with laboratory data management systems (LIMS, ELN, SDMS, CDS) and their integration patterns.

Additional Preferences:

• Understanding ofDesign of Experiments (DoE), Quality by Design (QbD), and process validation strategies.

• Experience implementing data mesh architectures in scientific organizations.

• Knowledge of MLOps practices and model deployment in validated environments.

• Familiarity withregulatory submissions(eCTD, CTD) and how analytical data supports marketing applications.

• Experience with CI/CD pipelines (GitHub Actions, CloudFormation) for scientific applications.

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

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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