Principal Scientist, Stat. Programming - A&r Standards, Innovation (hybrid)

Merck Merck · Pharma · PA

This role focuses on developing and delivering standards and tools for statistical programming in drug and vaccine development, with a mention of leveraging AI where appropriate. The primary focus is on R, Python, and SAS for data analysis and reporting, adhering to clinical trial and regulatory standards. While AI tools are mentioned as a preferred skill for enhancing coding efficiency, the core responsibilities do not involve building or shipping AI models or agents.

What you'd actually do

  1. 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.
  2. Address operational challenges that require strategic standard-based solutions, resulting in improved analysis and reporting deliverables.
  3. Facilitate global adoption of standards and programming best practices.
  4. Contribute to strategic solutions in support of cross functional stakeholder groups in BARDS, GCD, and our Research & Development Division.
  5. Provide technical consultation and analytical support to statistical programmers and statisticians.

Skills

Required

  • BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 12 or more years statistical programming experience in a clinical trial environment OR MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 10 or more years statistical programming experience in a clinical trial environment
  • Excellent interpersonal skills and ability to negotiate and collaborate effectively.
  • Excellent written, oral, and presentation skills.
  • Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
  • Excellent project management skills; leadership across multiple and complex programs; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders.
  • Expertise in clinical trial programming, including data manipulation, reporting workflows, visualization, and production-quality practices using multiple programming languages and tools.
  • Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) according to quality, compliance and timeliness requirements.
  • Strong knowledge and understanding of CDISC SDTM and ADaM analysis dataset standards.
  • Experience working with analytical research databases including various analysis datasets and procedures.
  • Demonstrated understanding of statistics, clinical trial, and data management concepts as applied to drug/vaccine development.
  • Demonstrated success in the assurance of deliverable quality and process compliance.
  • Strategic thinking - ability to analyze operational activities and challenges and develop and implement strategic solutions.
  • Ability to anticipate stakeholder requirements.
  • Ability and interest to work across cultures and geographies.
  • Clinical SAS Programming
  • Data Management
  • Data Modeling
  • Numerical Analysis
  • R Programming
  • Stakeholder Relationship Management

Nice to have

  • Experience developing flexible and efficient multilingual products for analysis and reporting using R, Python, SAS.
  • Experience with process assessment, improvement and operational excellence methodologies.
  • Experience developing and managing project plans.
  • Experience using AI/GenAI tools, such as Claude Code, to enhance coding, automation, and workflow efficiency.
  • Active in professional societies and ability to collaborate across regions.
  • Python (Programming Language)

What the JD emphasized

  • statistical programming experience in a clinical trial environment
  • setting strategy and developing analysis and reporting deliverables for R&D projects
  • Expertise in clinical trial programming
  • Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables
  • Strong knowledge and understanding of CDISC SDTM and ADaM analysis dataset standards.