Senior Scientist, Statistical Programming, Late-Stage Oncology (Remote)
$117,000–$184,200 year
RemoteUnited States
United StatesRemoteFull Time$117,000–$184,200 yearSenior LevelDoctorate Or Professional DegreeEnterprise
Full TimeSenior LevelDoctorate Or Professional DegreeEnterprise
Job Summary
Lead statistical programming for late-stage oncology clinical development projects, including safety and efficacy analysis datasets, tables, listings, and figures for regulatory submissions. Design and maintain complex statistical datasets supporting clinical development, outcomes research, and safety evaluation while ensuring compliance with CDISC, ADaM, and global standards. Manage project plans, forecast resources, and coordinate a global programming team including outsourced providers. Serve as the statistical programming point of contact throughout the product lifecycle, delivering high-quality analysis and reporting to stakeholders.
Required Qualifications
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field
- MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field
- minimum of 5 years SAS programming experience in a clinical trial environment
- minimum of 3 years SAS programming experience in a clinical trial environment
- Effective interpersonal skills and ability to negotiate and collaborate effectively
- Effective written, oral, and presentation skills
- Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
- A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders
- Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH
- systems and database expertise
- Ability to comprehend analysis plans which may describe methodology to be programmed
- an understanding of statistical terminology and concepts
- Familiarity with clinical data management concepts
- Experience in CDISC and ADaM standards
- Experience ensuring process compliance and deliverable quality
- Strategic thinking - ability to turn strategy into tactical activities
- design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices
- Ability to anticipate stakeholder requirements
- Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
- Experience developing and managing a project plan using Microsoft Project or similar package
- Active in professional societies
- Experience in process improvement
- Demonstrated proficiency in steering statistical programming deliverables post-DBL, ensuring absolute data integrity of unblinded data
- Strong capability to operate efficiently in high-pressure environments, swiftly addressing emergent post-DBL challenges through decisive stakeholder communication and rapid technical resolution
- Clinical Development
- Clinical Trials
- Data Management
- Data Modeling
- Leadership
- Numerical Analysis
- Outcomes Research
- Pressure Management
- Project Leadership
- Project Management
- Project Planning
- Stakeholder Relationship Management
- Statistical Programming
- US and Puerto Rico Residents Only
Desired Qualifications
- Demonstrated experience with advanced programming languages such as R (including Shiny) and/or Python
- familiarity with the application of Generative AI and emerging technologies within statistical programming pipelines
- Demonstrated success in the assurance of deliverable quality and process compliance
- Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
- US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables
- Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers
- experience as a programming mentor
- Ability and interest to work across cultures and geographies
- Experience developing and managing a project plan using Microsoft Project or similar package
- Open Source Technologies
- Open Source Tools
- Python (Programming Language)
- R Programming
- R Shiny
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