Senior Scientist Statistical Programming, Late-Stage (Hybrid)

MSD•North Wales, PA

3d•$117,000 - $184,200•Hybrid

About The Position

In BARDS (Biostatistics and Research Decision Sciences), a department within the Research and Development division, quantitative scientists partner with subject matter experts to apply scientific methodologies and tools supporting the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines. This position supports statistical programming activities for late-stage drug and vaccine clinical development projects and may lead one or more projects. It is accountable for developing and executing statistical analysis and reporting deliverables, including safety and efficacy analysis datasets, tables, listings, and figures, across individual clinical trials, worldwide regulatory application submissions, and post-marketing support. The role designs and maintains statistical datasets supporting clinical development, outcomes research, and safety evaluation stakeholders. The position collaborates with statistics and other project stakeholders to execute plans efficiently and deliver high-quality work on time. For assigned projects, it serves as the statistical programming point of contact and knowledge holder throughout the product lifecycle. The role also coordinates a global programming team that includes outsource-provider staff.

Requirements

Bachelor's degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or a related field and at least 5 years of SAS programming experience in a clinical trial environment; alternatively, a master's degree in one of these fields and at least 3 years of such experience.
Effective interpersonal skills and 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 project-level tasks independently, and collaborate with key stakeholders.
Significant expertise in SAS and clinical trial programming, including data steps, procedures, SAS/MACRO, SAS/GRAPH, systems, and databases.
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.

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 efforts, or serving as a programming mentor.
Ability and interest in working across cultures and geographies.
Experience completing statistical programming deliverables using global outsource partner programming staff.
Experience developing and managing project plans using Microsoft Project or a similar package.
Active participation in professional societies.
Experience in process improvement.

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 the activities of a global programming team, including outsource-provider staff.
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.
Collaborate with statistics and project stakeholders to ensure efficient execution and timely, high-quality deliverables.
Participate in departmental strategic initiative teams.