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

MSD•Rahway, NJ

14d•Hybrid

About The Position

Within BARDS (Biostatistics and Research Decision Sciences), part of the Research and Development division, this position leads statistical programming activities for multiple and/or large, complex late-stage drug and vaccine clinical development 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, across individual clinical trials, worldwide regulatory application submissions, and post-marketing support. The position designs and maintains statistical datasets supporting clinical development, outcomes research, and safety evaluation. It collaborates with statistics and other project stakeholders to execute project plans efficiently and deliver high-quality work on time. For assigned projects, the position serves as the statistical programming point of contact and knowledge holder throughout the product lifecycle. The role develops and validates analysis and report programming in accordance with global and therapeutic-area standards, departmental SOPs, and good programming practices. It also maintains project plans and resource forecasts, coordinates a global programming team that includes outsourced provider staff, and participates in departmental strategic initiative teams. The position is hybrid, based primarily in Rahway, New Jersey, with 10% travel. Domestic relocation and visa sponsorship are available.

Requirements

Bachelor's degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or a related field and at least 9 years of SAS programming experience in a clinical trial environment; alternatively, a master's degree in one of these fields and at least 7 years of such experience.
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 understand analysis plans and the statistical methodology to be programmed, with an understanding of 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 development of electronic submission deliverables.
Experience ensuring process compliance and deliverable quality.
Strategic thinking, including the ability to translate strategy into tactical activities and design statistical databases to optimize analysis and reporting while leveraging departmental standards and industry best practices.
Ability to anticipate stakeholder requirements.
Effective interpersonal skills and the ability to negotiate and collaborate effectively.
Effective written, oral, and presentation skills.
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 closely with key stakeholders to achieve project objectives.

Nice To Haves

Experience with GenAI tools, such as Python, R, R Shiny, or Claude.
Demonstrated success assuring deliverable quality and process compliance.
Strong working knowledge of reporting processes (SOPs) and the software development life cycle (SDLC).
Experience assuring programming consistency across protocols and projects.
Experience directing other programmers' program-development work and mentoring programmers.
Ability and interest in working 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 skills.
Oncology or oncology-trial experience.
Python programming experience.
R programming experience.

Responsibilities

Lead statistical programming activities for multiple and/or large, complex late-stage drug or vaccine clinical development projects.
Develop and validate analysis and reporting programs and deliverables, including safety and efficacy datasets, tables, listings, and figures, using global and therapeutic-area standards and departmental SOPs.
Design and maintain statistical datasets that support clinical development, outcomes research, and safety evaluation.
Support deliverables spanning clinical trials, worldwide regulatory application submissions, and post-marketing work.
Serve as the statistical programming point of contact and knowledge holder for assigned projects throughout the product lifecycle.
Collaborate with statistics and other project stakeholders to execute plans efficiently and deliver high-quality work on time.
Maintain and manage project plans, including resource forecasting.
Coordinate a global programming team that includes outsourced provider staff.
Participate in departmental strategic initiative teams.