Job Title: Principal/Statistical Programmer
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time Regular
Job ID: R-64916
About Eli Lilly:
Eli Lilly is a global leader in healthcare, working to discover life-changing medicines and improve disease management worldwide. With a strong emphasis on collaboration, innovation, and volunteerism, Lilly's employees strive to make life better for people across the globe.
Position Overview:
The Principal Statistical Programmer will play an essential role in supporting programming activities for clinical trial data analysis. This includes creating standard datasets (SDTM and ADaM), generating reports (Tables, Listings, and Graphs), and assisting in the preparation of regulatory documentation. The role requires close collaboration with statistical colleagues and study personnel, as well as staying up-to-date with SAS programming and statistical methodology.
Key Responsibilities:
Data Analysis & Reporting:
Support the programming activities for clinical trial data analysis.
Create standard datasets (SDTM) and analysis datasets (ADaM).
Generate reports, including Tables, Listings, and Graphs.
Collaborate with statistical colleagues to define statistical methods for data analysis.
Assist in writing sections of the data analysis plan and conducting the analysis once the reporting database is created.
Collaboration & Communication:
Work with other statistical and study teams to ensure efficient planning and execution of analysis.
Communicate study results and inferences clearly to stakeholders and regulatory bodies.
Respond to regulatory queries in collaboration with other statistical colleagues.
Documentation & Quality Assurance:
Assist with the creation of documentation, including Define, RGs, and CRT packages.
Collaborate with data management to implement data quality assurance plans.
Therapeutic & Systems Knowledge:
Develop a deep understanding of disease states to enhance collaboration and customer focus.
Stay informed on the latest technologies and tools in clinical trial analysis.
Regulatory Compliance:
Perform all work in compliance with corporate, medical, and regulatory policies and procedures.
Ensure the integrity and quality of the work performed in accordance with company standards.
Minimum Qualifications:
Education: Bachelor's degree or higher in a relevant field (e.g., statistics, mathematics).
Experience: Strong experience in SAS programming and statistical analysis methods.
Skills:
Experience with clinical trial data analysis and reporting.
Ability to select statistical methods and author corresponding sections of analysis plans.
Strong attention to detail and the ability to justify methods used.
Excellent collaboration and communication skills with both internal teams and external stakeholders.
Additional Preferences:
Experience with the analysis of clinical trial data and regulatory submissions.
Knowledge of statistical methodologies and techniques in clinical trials.
Ability to work with cross-functional teams and deliver results on time.
Additional Information:
Travel: Limited travel required.
Location: Eli Lilly's office in Bangalore, Karnataka, India.
Commitment to Inclusion: Lilly is committed to helping individuals with disabilities actively engage in the workforce and offers reasonable accommodations during the application process.
How to Apply:
To apply or learn more about this position, visit the Eli Lilly Careers page.
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