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

Jobtailor; New Jersey; On-site; USD 130,000 - 180,000; Full time

Job summary

Jobtailor in New Jersey seeks a senior SAS Programmer Leader to direct statistical programming activities for late-stage drug and vaccine development programs. You will develop and validate analysis datasets, tables, listings, and figures supporting global regulatory submissions and post-marketing activities.

The role requires strong leadership and deep SAS expertise (SAS/MACRO, SAS/GRAPH), CDISC ADaM and CDISC standards, and the ability to coordinate cross-functional teams across regions.

Qualifications

• BA/BS in Computer Science 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

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

Skills

SAS Programming

CDISC ADaM

Regulatory Submissions

Project Management

Statistical Programming Leadership

Education

Bachelor's degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field

Master's degree in the same fields

Tools

SAS/MACRO

SAS/GRAPH

Data Steps

CDISC Standards

ADaM Standards

Job description

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

Requirements

• 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

Core Competencies

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.

Highest-signal resume keywords

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

Hard Skills

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

Soft Skills

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

Industry Keywords

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

Tools & Technologies

• Statistical Software
• Database Management Systems