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

MSD•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 and may lead 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. Deliverables may cover individual clinical trials, worldwide regulatory application submissions, and post-marketing support. The incumbent designs and maintains statistical datasets that support clinical development, outcomes research, and safety evaluation. As a key collaborator with statistics and other project stakeholders, the role helps ensure project plans are executed efficiently and deliverables are timely and high quality. For assigned projects, the position serves as the statistical programming point of contact and knowledge holder throughout the product lifecycle.

Requirements

A BA/BS 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 an MS in one of these fields, plus at least 3 years of such experience.
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, SAS/GRAPH, systems, and databases.
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 ensuring process compliance and deliverable quality.
Strategic thinking and ability to translate strategy into tactical activities, including designing statistical databases with analysis and reporting needs in mind and applying 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).
US and/or worldwide drug or vaccine regulatory application submission experience, including developing electronic submission deliverables.
Experience assuring programming consistency across protocols and projects, directing other programmers' program development efforts, or 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.
Preferred skills include oncology, Python, R programming, and artificial intelligence software.

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.
Contribute as a member of departmental strategic initiative teams.