Sr. Scientist, Stat. Programming, Late-Stage Oncology (Hybrid)

About the role

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our Company's renowned Research and Development division, quantitative scientists partner with subject matter experts to apply state-of-the-art scientific methodologies and tools. This enables the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

This position supports statistical programming activities for late-stage drug/vaccine clinical development projects, which may include leadership of one or more projects. Accountability includes the development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures). These deliverables range from individual clinical trials to worldwide regulatory application submissions and post-marketing support.

The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups, including clinical development, outcomes research, and safety evaluation. The position serves as a key collaborator with statistics and other project stakeholders to ensure project plans are executed efficiently with timely and high-quality deliverables. For assigned projects, the role acts as the statistical programming point of contact and knowledge holder throughout the entire product lifecycle.

Responsibilities

• Effective analysis and report programming development and validation utilizing global and therapeutic area (TA) standards, following departmental SOPs and good programming practices.
• Maintain and manage a project plan, including resource forecasting.
• Coordinate the activities of a global programming team, including outsource provider staff.
• Membership on departmental strategic initiative teams.
• Design and develop complex programming algorithms.
• Comprehend analysis plans, including statistical methodology to be programmed, and understand statistical terminology and concepts.
• Ensure process compliance and deliverable quality.
• Develop statistical databases with the end in mind, optimizing analysis and reporting while leveraging departmental standards and industry best practices.
• Anticipate stakeholder requirements.
• Assure programming consistency across protocols and projects; direct the program development effort of other programmers.
• Develop and manage a project plan using Microsoft Project or a similar package.

Requirements

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or a related field plus a minimum of 5 years of SAS programming experience in a clinical trial environment, OR
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or a related field plus a minimum of 3 years of SAS programming experience in a clinical trial environment.
• Significant expertise in SAS and clinical trial programming, including data steps, procedures, SAS/MACRO, SAS/GRAPH, systems, and database expertise.
• Familiarity with clinical data management concepts and CDISC/ADaM standards.
• Experience ensuring process compliance and deliverable quality.
• Strategic thinking—ability to turn strategy into tactical activities.
• Effective interpersonal skills and ability to negotiate and collaborate effectively.
• Strong written, oral, and presentation skills.
• Experience developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Project leadership skills; ability to complete tasks independently at a project level and collaborate with key stakeholders.

Preferred Qualifications

• Experience with GenAI tools (e.g., Python, R, R Shiny, Claude).
• Demonstrated success in assuring deliverable quality and process compliance.
• Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC).
• US and/or worldwide drug or vaccine regulatory application submission experience, including the development of electronic submission deliverables.
• Experience as a programming mentor.
• Ability and interest in working across cultures and geographies.
• Experience completing statistical programming deliverables using global outsource partner programming staff.
• Active involvement in professional societies.
• Experience in process improvement.
• Expertise in oncology, Python, or R programming.

Benefits

We offer a comprehensive package of benefits, including:

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

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Pay

The salary range for this role is $117,000.00 - $184,200.00. This reflects the lowest to highest salary we in good faith believe we would pay for this role at the time of posting. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

Schedule

• Hybrid work arrangement.
• 10% travel requirements.

VISA sponsorship is available for this role.