Senior Scientist, Statistical Programming, Late-Stage Oncology (Remote)

About the role

This position supports statistical programming activities for late-stage drug/vaccine clinical development projects within BARDS (Biostatistics and Research Decision Sciences), a distinguished department in our Company's renowned Research and Development division. The role may include leadership of one or more projects and involves developing and executing statistical analysis and reporting deliverables, ranging from individual clinical trials to worldwide regulatory submissions and post-marketing support.

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

Responsibilities

• Develop and validate analysis and report programming using global and therapeutic area (TA) standards, following departmental SOPs and good programming practices.
• Maintain and manage a project plan, including resource forecasting.
• Coordinate activities of a global programming team, including outsource provider staff.
• Serve as a member on departmental strategic initiative teams.
• Design and develop complex programming algorithms.
• Comprehend analysis plans, including statistical methodology, terminology, and concepts.
• Ensure process compliance and deliverable quality.
• Apply strategic thinking to design statistical databases with the end goal in mind, leveraging departmental standards and industry best practices.
• Anticipate stakeholder requirements and ensure programming consistency across protocols and projects.
• Direct and mentor other programmers.
• Develop and manage project plans using tools like Microsoft Project.
• Steer statistical programming deliverables post-database lock (DBL), ensuring data integrity of unblinded data.
• Operate efficiently in high-pressure environments, addressing emergent post-DBL challenges through decisive stakeholder communication and rapid technical resolution.

Requirements

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or related field plus a minimum of 5 years of SAS programming experience in a clinical trial environment, OR an MS in the same fields 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 management.
• Familiarity with clinical data management concepts and CDISC/ADaM standards.
• Effective interpersonal, negotiation, collaboration, written, oral, and presentation skills.
• Experience developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Ability to work independently at a project level and collaborate with key stakeholders.
• Experience working across cultures and geographies.
• Ability to complete statistical programming deliverables using global outsource partner programming staff.

Preferred Qualifications

• Demonstrated experience with advanced programming languages such as R (including Shiny) and/or Python.
• Familiarity with the application of Generative AI and emerging technologies within statistical programming pipelines.
• 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 development of electronic submission deliverables.
• Experience in process improvement and active participation in professional societies.
• Demonstrated proficiency in steering post-DBL deliverables and ensuring data integrity.

Pay

The salary range for this role is $117,000.00 - $184,200.00. 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 needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits, including:

• Medical, dental, vision, and other insurance benefits for employees and their families.
• Retirement benefits, including a 401(k) plan.
• Paid holidays, vacation, compassionate, and sick days.

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

Schedule

• Travel Requirements: 10%
• Flexible Work Arrangements: Remote options available

This is a regular, full-time position. Relocation assistance is available for domestic moves. Visa sponsorship is provided for this role.