Senior Scientist – Analysis and Reporting Standards, Innovation

• Support the design, development, and delivery of efficient, flexible, and modular analysis and reporting and submission standards and tools that can be used for drug and/or vaccine projects across all therapeutic areas
• Adhere to standard operating procedures and guidelines established by the department
• Drive data structures which includes analysis and reporting data standards and submission standards and actively contribute to the department's strategic initiatives
• Develop and validate global programming standards for ADaM datasets
• Develop and validate global programming standards for efficacy analysis and reporting
• Develop and validate global programming standards for safety analysis and reporting
• Design and develop complex programming algorithms
• Provide technical consultation and analytical support to statistical programmers and statisticians

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years of statistical programming experience in a clinical trial environment
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years of statistical programming experience in a clinical trial environment
• Excellent interpersonal skills and ability to negotiate and collaborate effectively
• Excellent written, oral, and presentation skills
• Knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, listings, figures)
• A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders
• Expertise in clinical trial programming, including data manipulation, reporting workflows, visualization, and production-quality practices using multiple programming languages and tools
• Knowledge and understanding of CDISC SDTM and ADaM analysis dataset standards
• Experience working with analytical research databases including various analysis datasets and procedures
• Demonstrated understanding of statistics, clinical trial, and data management concepts as applied to drug/vaccine development
• Experience developing flexible and efficient multilingual products for analysis and reporting using R, Python, SAS
• Experience using AI/GenAI tools, such as Claude Code, to enhance coding, automation, and workflow efficiency
• Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts;
  Implements statistical methods not currently available through commercial software packages
• Ability and interest to work across cultures and geographies
• Active in professional societies eligibleforERP SPjobs BARDS
  2020 VETJOBS EBRG

Demonstrates expertise in statistical programming for clinical trials, including proficiency in R, Python, and SAS, while adhering to CDISC SDTM and ADaM standards. Capable of developing and validating analysis and reporting deliverables, with strong interpersonal and communication skills for effective collaboration across teams.

• Statistical Programming Experience
• CDISC SDTM and ADaM Standards
• R, Python, SAS Proficiency
• Data Manipulation and Reporting Workflows
• Interpersonal and Communication Skills

• Statistical Programming
• Data Manipulation
• Analysis and Reporting Deliverables
• Programming Algorithms
• Statistical Methods Implementation
• Data Structures Development
• Efficacy Analysis
• Safety Analysis
• Clinical Trial Programming
• Multilingual Product Development

• Interpersonal Skills
• Negotiation Skills
• Collaboration Skills
• Presentation Skills
• Project Leadership

• Clinical Trials
• Drug Development
• Vaccine Development
• Statistical Terminology
• Data Management Concepts

• R
• Python
• SAS
• AI/GenAI Tools
• Analytical Research Databases