Associate Principal Scientist, Statistical Programming, Late-Stage Oncology (Hybrid)

Merck•North Wales, PA

9d•$142,400 - $224,100•Hybrid

About The Position

In BARDS (Biostatistics and Research Decision Sciences), a department within Research and Development, quantitative scientists work 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 leads statistical programming activities for multiple and/or large or complex late-stage drug and vaccine clinical development projects. The role is accountable for developing and executing statistical analysis and reporting deliverables, including safety and efficacy analysis datasets, tables, listings, and figures. Deliverables span individual clinical trials, worldwide regulatory application submissions, and post-marketing support. The incumbent designs and maintains statistical datasets supporting clinical development, outcomes research, and safety evaluation. The role collaborates with statistics and project stakeholders to execute plans efficiently and deliver high-quality work on time. For assigned projects, the incumbent is the statistical programming point of contact and knowledge holder throughout the product lifecycle. The position coordinates a global programming team, including outsourced provider staff, and maintains project plans and resource forecasts. The role also contributes to departmental strategic initiative teams.

Requirements

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or a related field, plus at least 9 years of SAS programming experience in a clinical trial environment; OR an MS in one of these fields or a related field, plus at least 7 years of SAS programming experience in a clinical trial environment.
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 large and/or complex projects, balance competing priorities, and collaborate with stakeholders to achieve project objectives.
Significant expertise in SAS and clinical trial programming, including data steps, procedures, SAS/MACRO, and SAS/GRAPH; systems and database expertise.
Ability to design and develop complex programming algorithms.
Ability to comprehend analysis plans and understand statistical terminology and concepts.
Familiarity with clinical data management concepts.
Experience with CDISC and ADaM standards.
Experience with US and/or worldwide drug or vaccine regulatory application submissions, including electronic submission deliverables.
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 Python, R, R Shiny, or 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 assuring programming consistency across protocols and projects, directing other programmers' program development, and mentoring programmers.
Ability and interest to work across cultures and geographies.
Ability to complete 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.
Leadership experience.
Oncology or oncology trials experience.
Python programming or R programming.

Responsibilities

Develop and validate analysis and reporting programs using global and therapeutic-area standards, departmental SOPs, and good programming practices.
Maintain and manage project plans, including resource forecasting.
Coordinate the work of a global programming team, including staff from outsource providers.
Lead statistical programming for multiple and/or large or complex late-stage drug or vaccine clinical development projects.
Develop and execute statistical analysis and reporting deliverables, including safety and efficacy datasets, tables, listings, and figures, for clinical trials, regulatory submissions, and post-marketing support.
Design and maintain statistical datasets that support clinical development, outcomes research, and safety evaluation.
Collaborate with statistics and project stakeholders to ensure efficient execution and timely, high-quality deliverables.
Serve as the statistical programming point of contact and knowledge holder for assigned projects through the product lifecycle.
Participate in departmental strategic initiative teams.