remote
Sr. Scientist - Analysis and Reporting Standards, Innovation Hybrid - Merck
Software Engineer
Senior Scientist leading the design, development, and delivery of modular analysis and reporting standards for clinical data, leveraging advanced statistical methods and programming in R, Python, and SQL to support regulatory submissions and innovation in drug development.
About the role
Key Responsibilities
- Design, develop, and maintain scalable analysis frameworks and reporting standards for clinical and translational studies.
- Collaborate with cross‑functional teams to translate scientific questions into reproducible statistical analyses.
- Implement and validate statistical models using R, Python, and SQL, ensuring compliance with regulatory guidelines.
- Document methodologies, create reproducible workflows, and provide training to internal stakeholders.
- Lead continuous improvement initiatives to enhance data quality, analysis efficiency, and reporting accuracy.
Requirements
- Ph.D. or M.S. in Biostatistics, Statistics, or related field with 5+ years of industry experience.
- Proficiency in R and Python for statistical programming and data manipulation.
- Strong SQL skills for data extraction and management.
- Experience with regulatory submissions (IND, NDA, BLA) and familiarity with FDA/EMA guidelines.
- Excellent communication skills and ability to mentor junior analysts.