Senior Scientist Statistical Programming, Late-Stage (Hybrid)

Merck • North Wales, PA

6d • $117,000 - $184,200 • Hybrid

About The Position

This position supports statistical programming activities for late-stage drug and vaccine clinical development projects, potentially leading one or more projects. The role is primarily accountable for developing and executing statistical analysis and reporting deliverables, including safety and efficacy analysis datasets, tables, listings, and figures. Work ranges from individual clinical trials to worldwide regulatory application submissions and post-marketing support.

The position designs and maintains statistical datasets for stakeholder groups including clinical development, outcomes research, and safety evaluation. It collaborates with statistics and other project stakeholders to execute project plans efficiently and deliver high-quality work on time. For assigned projects, the role serves as the statistical programming point of contact and knowledge holder throughout the product lifecycle.

The role is within BARDS (Biostatistics and Research Decision Sciences), part of the Research and Development division. BARDS quantitative scientists partner with subject matter experts and use scientific methodologies and tools to support the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines.

Requirements

• A bachelor's degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or a related field, plus at least 5 years of SAS programming experience in a clinical trial environment; or a master's degree in one of these fields, plus at least 3 years of SAS programming experience in a clinical trial environment.
• Effective interpersonal skills and the ability to negotiate and collaborate effectively.
• Effective written, oral, and presentation skills.
• Knowledge and experience developing analysis and reporting deliverables for R&D projects, including data, analyses, tables, graphics, and listings.
• Ability to lead projects, complete tasks independently at the project level, and collaborate with key stakeholders.
• Significant expertise in SAS and clinical trial programming, including data steps, procedures, SAS/MACRO, and SAS/GRAPH, as well as systems and database expertise.
• Ability to design and develop complex programming algorithms.
• Ability to understand analysis plans and statistical terminology and concepts.
• Familiarity with clinical data management concepts.
• Experience with CDISC and ADaM standards.
• Experience ensuring process compliance and deliverable quality.
• Strategic thinking, including translating strategy into tactical activities and designing statistical databases to optimize analysis and reporting while leveraging departmental standards and industry best practices.
• Ability to anticipate stakeholder requirements.
• Required skills listed in the posting include CDISC ADaM, CDISC standards, clinical SAS programming, clinical trials, data management, data modeling, macro programming, numerical analysis, stakeholder relationship management, and the Waterfall Model.

Nice To Haves

• Experience with GenAI tools, such as R, R Shiny, R Force, or Python Claude.
• Demonstrated success assuring deliverable quality and process compliance, with strong working knowledge of reporting processes (SOPs) and the software development life cycle (SDLC).
• Experience with U.S. and/or worldwide drug or vaccine regulatory application submissions, including electronic submission deliverables.
• Experience assuring programming consistency across protocols and projects, directing other programmers' program development, or mentoring programmers.
• Ability and interest in working across cultures and geographies.
• Ability to complete statistical programming deliverables using global outsource partner programming staff.
• Experience developing and managing a project plan using Microsoft Project or a similar package.
• Active participation in professional societies.
• Experience in process improvement.
• Preferred skills listed in the posting include Python, regulatory submissions, and R programming.

Responsibilities

• Develop and validate analysis and report programming using global and therapeutic-area standards, departmental SOPs, and good programming practices.
• Maintain and manage project plans, including resource forecasting.
• Coordinate a global programming team, including staff from outsource providers.
• Serve as the statistical programming point of contact and knowledge holder for assigned projects throughout the product lifecycle.
• Design and maintain statistical datasets supporting clinical development, outcomes research, and safety evaluation stakeholder groups.
• Develop and execute statistical analysis and reporting deliverables, including safety and efficacy analysis datasets, tables, listings, and figures.
• Contribute as a member of departmental strategic initiative teams.

Benefits

• Annual bonus and long-term incentive, if applicable.
• Medical, dental, vision healthcare, and other insurance benefits for employees and families.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, compassionate days, and sick days.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior