Associate Principal Scientist, Statistical Programming, Late-Stage – Non-Oncology

Responsibilities

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

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 9 years SAS programming experience in a clinical trial environment, OR MS in one of these fields plus a minimum of 7 years SAS programming experience in a clinical trial environment
• Excellent interpersonal, written, oral, and presentation skills
• Broad knowledge and significant experience developing analysis and reporting deliverables for R&D projects
• Strong project management skills and program-level leadership
• Significant expertise in SAS and clinical trial programming, including data steps, procedures, SAS/MACRO, and SAS/GRAPH
• Systems and database expertise
• Experience leading large and/or complex statistical programming projects and coordinating programming teams
• US and/or worldwide drug or vaccine regulatory application submission experience at leadership level, including electronic submission deliverables
• 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
• Demonstrated success assuring deliverable quality and process compliance
• Strategic thinking and ability to translate strategy into tactical activities
• Ability to anticipate stakeholder requirements
• Required skills:
  
  CDISC ADaM, CDISC Standards, Project Management, Regulatory Submissions, Stakeholder Relationship Management, SAS Programming
• Visa sponsorship available

Demonstrates extensive expertise in SAS Programming and statistical analysis for clinical trials, with a strong focus on regulatory submissions and project management. Proven ability to lead programming teams and ensure high-quality deliverables in compliance with CDISC standards.

• SAS Programming
• CDISC ADaM
• Regulatory Submissions
• Project Management
• Statistical Programming Leadership

• SAS Programming
• Statistical Analysis
• Data Steps
• SAS/MACRO
• SAS/GRAPH
• Programming Algorithms
• Analysis Plans Comprehension
• CDISC Standards
• ADaM Standards
• Clinical Trial Programming

• Interpersonal Skills
• Written Communication
• Oral Communication
• Presentation Skills
• Strategic Thinking

• Clinical Development
• Drug Development
• Vaccine Development
• Regulatory Application
• Stakeholder Relationship Management

• Statistical Software
• Database Management Systems