Principal Scientist, Stat. Programming - A&R Standards, Innovation (Hybrid)
Merck · North Wales, Pennsylvania, United States
About this role
<p style="text-align:left"><b>Job Description</b></p><p style="text-align:inherit"></p><p>In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.</p><p></p><p><b><u>Responsibilities</u></b>:</p><p>This position supports the strategic design, development, and delivery of efficient, flexible, and modular analysis and reporting and submission standards and tools that can be used for drug and/or vaccine projects across all therapeutic areas. Adheres to standard operating procedures and guidelines established by the department. Drives data structures which include analysis and reporting data standards and submission standards
Actively leads and contributes to the department's strategic initiatives.</p><p></p><p>The position is a key collaborator with internal and external stakeholders including Biostatistics, Statistical Programming, Data Management, Clinical Research, Regulatory, Observational Research, Clinical Safety, and PK/PD Modeling and Simulation organizations.</p><p></p><p><b>Primary Activities:</b></p><ul><li><p>Drive the development and adoption of scalable, reusable multilingual standards library based on R, Python and SAS with an emphasis on open-source adoption and automation, leveraging AI where appropriate.</p></li><li><p>Address operational challenges that require strategic standard-based solutions, resulting in improved analysis and reporting deliverables.</p></li><li><p>Facilitate global adoption of standards and programming best practices.</p></li><li><p>Contribute to strategic solutions in support of cross functional stakeholder groups in BARDS, GCD, and our
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