Senior Scientist, Statistical Programming, Late-Stage Oncology

• Develop and validate statistical analysis and reporting programs using global and therapeutic-area standards, departmental SOPs, and good programming practices
• Develop safety and efficacy analysis datasets, tables, listings, and figures for clinical trials, regulatory submissions, and post-marketing support
• Design and maintain statistical datasets supporting clinical development, outcomes research, and safety evaluation stakeholders
• Serve as statistical programming point of contact and knowledge holder throughout the product lifecycle
• Maintain and manage project plans, including resource forecasting
• Coordinate global programming teams, including outsourced provider staff
• Collaborate with statisticians and other project stakeholders to execute plans efficiently and deliver high-quality outputs on time
• Participate on departmental strategic initiative teams
• Ensure programming process compliance, deliverable quality, and consistency across protocols and projects
• Direct other programmers' program development efforts and provide programming mentorship when applicable

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or related field plus at least 5 years of SAS programming experience in a clinical trial environment, OR MS in one of these fields plus at least 3 years of such experience
• Effective interpersonal, negotiation, collaboration, 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 projects, complete tasks independently at project level, and collaborate with key stakeholders
• 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 ensuring process compliance and deliverable quality
• Ability to translate strategy into tactical activities and design optimized statistical databases
• Ability to anticipate stakeholder requirements
• Preferred: experience with GenAI tools such as Python, R, R Shiny, and Claude
• Preferred: drug or vaccine regulatory application submission experience
• Preferred: experience directing other programmers and mentoring
• Preferred: experience with Microsoft Project or similar package
• Preferred: professional society involvement and process improvement experience
• Ability and interest to work across cultures and geographies
• Oncology experience preferred

Demonstrates expertise in SAS programming for clinical trials, including the development of statistical analysis datasets and reporting deliverables. Proven ability to lead projects, ensure compliance, and collaborate effectively with cross-functional teams.

• SAS Programming
• Clinical Trial Programming
• Statistical Analysis
• CDISC and ADaM Standards
• Project Management

• Statistical Analysis
• SAS/MACRO
• SAS/GRAPH
• Programming Algorithms
• Data Management
• Statistical Datasets
• Analysis Plans
• Deliverable Quality
• Resource Forecasting
• Process Compliance

• Interpersonal Skills
• Collaboration
• Negotiation
• Presentation Skills
• Mentorship

• Clinical Trials
• Regulatory Submissions
• Oncology
• Life Sciences
• Outcomes Research

• Microsoft Project
• GenAI Tools
• Python
• R
• R Shiny