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Principal C&SP Methodology Lead
Johnson & Johnson. Provide technical project leadership and expertise for Clinical and Statistical Programming Therapeutic Area or assigned groups .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical and Statistical Programming, with proficiency in SAS, R, and Python for developing automation solutions and enhancing data management processes. Capable of leading teams, managing performance, and ensuring compliance with health authority guidelines.
Highest-signal resume keywords
SAS ProgrammingR ProgrammingPython DevelopmentClinical Data ManagementProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
SAS MacrosR Functions/PackagesSoftware Development Life Cycle (SDLC)Data ManipulationAutomation SolutionsStatistical AnalysisVisualization TechniquesCDISC StandardsContinuous ImprovementTechnical Project Leadership
Soft Skills
Strong Communication SkillsConflict ManagementNegotiation SkillsTeam LeadershipTalent Development
Tools & Technologies
DevOps ToolsCloud-Based PlatformsData Transparency ToolsDocumentation ToolsTraining Materials
Industry Keywords
ICH-GCP21 CFR Part 11Clinical R&D ConceptsRisk-Based Central MonitoringTherapeutic Area Efficiency
Tech Stack
Tools & technologiesCloudPythonSDLC
About the role
Key responsibilities & impact- Provide technical project leadership and expertise for Clinical and Statistical Programming Therapeutic Area or assigned groups
- Research and innovate in emerging technical areas and develop standard tools
- Identify, evaluate and develop automation and continuous improvement solutions
- Support innovation in data management, risk-based central monitoring, statistical analysis, visualization and regulatory submission of clinical data
- Lead or contribute to departmental innovation, process improvement and Therapeutic Area efficiency projects
- Collaborate with users, departmental and external stakeholders to identify opportunities and propose solutions
- Oversee work allocation of internal and external team members as needed
- Design and support implementation of global technical solutions, including documentation and training materials
- Improve application performance and recommend technology strategies
- Develop or oversee SAS macros, R functions/packages and other tools automating clinical and statistical programming activities
- Provide technical support and training
- Collaborate with Clinical & Statistical Programming, Data Management, Biostatistics, Risk Management Central Monitoring, IT, Data Sciences and other partner functions
- Attract and retain talent, manage performance, support talent development and succession planning when acting as functional manager/people leader
- Ensure training compliance and develop job skills for assigned personnel
- Consider data and patient privacy requirements when working with the Data Transparency group
Requirements
What you’ll need- Bachelor’s degree or equivalent in computer science, mathematics, data science/analytics, public health or another relevant scientific field preferred, or equivalent theoretical/technical depth or relevant industry experience
- 6–8 years of programming experience with increasing responsibility
- Experience in software development and testing, including SAS macros/tools and R functions/packages
- Expertise developing applications using technical stacks including SAS, R and/or Python
- Ability to translate complex problems into clear and concise programming code/tools
- Basic project management skills and experience
- Working knowledge of programming practices, relevant health authority guidelines such as ICH-GCP and 21 CFR Part 11, and clinical R&D concepts
- Strong written and verbal communication skills
- Ability to manage conflicting demands and priorities and negotiate successfully
- Experience working and leading in a matrix environment
- Knowledge of data structures and languages for data manipulation and reporting, including SAS, R and Python
- Knowledge of CDISC standards, specifically SDTM, controlled terminology and/or ADaM
- Experience with software development life cycle (SDLC)
- Experience developing tools supporting business operations
- Experience with DevOps tools and cloud-based platforms
- Demonstrated people management, staff performance management and people development skills
Benefits
Comp & perks- Inclusive work environment
- Training and coaching opportunities
- Talent development and succession planning
- Performance management and people development support