Job Title: Principal / Statistical Programmer
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full-Time, Regular
Job ID: R-64916
Company Overview:
Eli Lilly and Company is a global leader in healthcare innovation, dedicated to discovering life-changing medicines and improving lives. Headquartered in Indianapolis, Indiana, Lilly operates worldwide with a focus on delivering impactful treatments, fostering collaboration, and giving back to communities.
Role Summary:
The Principal / Statistical Programmer will support statistical programming activities related to clinical trials, including creation of SDTM and ADaM datasets, and generation of clinical reports such as Tables, Listings, and Graphs. The role involves close collaboration with statisticians, data managers, and regulatory teams to support study submissions and ensure data quality and compliance.
Key Responsibilities
1. Programming & Data Analysis
Create SDTM and ADaM datasets per regulatory and study requirements.
Generate Tables, Listings, and Graphs for clinical trial reporting.
Develop Define.xml files, Reviewer’s Guides (RGs), and CRT packages.
2. Collaboration & Documentation
Partner with statisticians to develop and implement statistical analysis plans.
Select and justify statistical methods used in data analysis.
Peer review programming deliverables to ensure quality and accuracy.
3. Compliance & Quality Assurance
Work in compliance with internal SOPs, policies, and regulatory guidelines.
Partner with data management on data quality plans and validation activities.
Stay current with statistical methodologies, tools, and industry standards.
4. Communication & Reporting
Help author reports and regulatory documents.
Assist in responding to regulatory agency queries.
Communicate clinical study findings clearly and effectively.
5. Therapeutic & Systems Knowledge
Maintain understanding of assigned therapeutic areas to support data interpretation.
Promote reuse of systems, tools, and templates where applicable.
Qualifications
Proficiency in SAS programming and clinical trial data standards (e.g., CDISC).
Demonstrated experience with SDTM/ADaM datasets, Define.xml, TFL generation.
Strong collaboration and documentation skills.
Understanding of statistical methodologies and regulatory submission standards.
Inclusivity Statement
Lilly provides equal employment opportunities and is committed to accommodating individuals with disabilities throughout the hiring process.
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