Associate Principal Scientist, Statistical Programming, Late-Stage Oncology (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. Work spans 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 position helps ensure efficient project execution and timely, high-quality deliverables. For assigned projects, the role serves as the statistical programming point of contact and knowledge holder throughout the product lifecycle. The role develops and validates analysis and report programs using 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 outsource provider staff, and participates in departmental strategic initiative teams. The position is hybrid, based primarily in Rahway, New Jersey, and may involve 10% travel.
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, plus at least 7 years of SAS programming experience in a clinical trial environment.
- 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 large and/or complex projects, balance competing priorities, and collaborate closely with key stakeholders to achieve project objectives.
- 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 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.
Nice To Haves
- Experience with GenAI tools, such as Python, R, R Shiny, or Claude.
- Demonstrated success ensuring 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 serving as a programming mentor.
- 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 a project plan using Microsoft Project or a similar package.
- Active participation in professional societies.
- Experience in process improvement.
Responsibilities
- Lead statistical programming activities for multiple and/or large or complex late-stage drug and vaccine clinical development projects.
- Develop and execute statistical analysis and reporting deliverables, including safety and efficacy analysis datasets, tables, listings, and figures.
- Design and maintain statistical datasets supporting clinical development, outcomes research, and safety evaluation.
- Develop and validate analysis and report programs using global and therapeutic-area standards, departmental SOPs, and good programming practices.
- Maintain and manage project plans, including resource forecasting.
- Coordinate 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.
- Collaborate with statistics and other project stakeholders to execute project plans efficiently and deliver high-quality work on time.
- Participate in departmental strategic initiative teams.
Benefits
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays.
- Vacation.
- Compassionate and sick days.
- Eligible for an annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
