Senior Statistical Programmer

• Provide high quality statistical programming deliverables for global stakeholders in Early Development Statistics and/or PK/PD Modeling and Simulation spanning all our Company's therapeutic areas.
• Gather and interpret user requirements for programming requests, retrieve required data, transform data into analysis/modeling datasets, and develop tables, listings and figures according to statistical/modeling analysis plan.
• Partner with stakeholders to solve problems; reduce the amount of programming tasks being completed by stakeholders to facilitate an increase in efficiency and compliance for the analyses.
• Write programs to analyze data with statistical methods which are not currently available through commercial software packages.
• Key collaborator with statisticians, pharmacokinetic (PK) modelers, and other project stakeholders.
• Programmatically develop, validate and maintain complex datasets, tables, listings, and figures.
• Provide technical consultation and analytical support to statisticians and PK modelers for exploratory and unplanned statistical analyses.
• Prepare compliant programming code for regulatory submissions including analysis datasets, tables, listings, figures and associated documentation.
• Ensure programmatic traceability from data source to analysis / modeling result.
• Support the development of programming standards to enable efficient and high quality production of programming deliverables.

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS/R programming experience in a clinical trial environment
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS/R programming experience in a clinical trial environment
• Effective interpersonal skills and ability to negotiate and collaborate effectively
• Effective knowledge and experience in developing analysis and reporting deliverables for research and development projects (data, analyses, tables, graphics, listings)
• A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders
• Experience in CDISC SDTM and ADaM standards
• Significant SAS or R programming experience for data manipulation, analysis and reporting
• Designs and develops complex programming algorithms
• 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
• Demonstrated ability to work in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes

Demonstrates expertise in SAS and R programming for statistical analysis and data manipulation within clinical trial environments, ensuring compliance with CDISC SDTM and ADaM standards. Capable of developing complex programming algorithms and providing technical consultation to stakeholders while maintaining high-quality programming deliverables.

• SAS Programming Experience
• R Programming Experience
• CDISC SDTM Standards
• CDISC ADaM Standards
• Statistical Analysis Methods

• Statistical Programming
• Data Manipulation
• Analysis Deliverables Development
• Complex Programming Algorithms
• Regulatory Submissions Programming

• Interpersonal Skills
• Collaboration
• Negotiation
• Project Leadership

• Clinical Trial Environment
• Pharmaceutical Development Processes
• Exploratory Environment
• Statistical Terminology
• Modeling and Simulation