Scientist, Statistical Programming-PKPD (Hybrid PA/NJ)

Role Summary

Scientist, Statistical Programming-PKPD (Hybrid PA/NJ). Provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early and late Development PK/PD modeling and simulation, spanning both early and late-stage Oncology studies. Develops and executes statistical modeling datasets, tables, listings, figures, and regulatory submission deliverables under guidance, collaborating with statisticians, modelers, clinical teams, and outsource partners.

Responsibilities

• Programmatically develop, validate and maintain modeling datasets, tables, listings and figures at study / protocol level
• Assure deliverables quality and compliance with departmental SOPs and good programming practices
• Collaborate effectively with project team members including outsource provider staff
• 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
• Represent statistical programming on process improvement activities

Qualifications

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 2 years SAS programming experience in a clinical trial environment
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field
• Good interpersonal skills and ability to negotiate and collaborate effectively
• Good written, oral, and presentation skills
• Knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
• Takes direction effectively and completes tasks at a project level; ability to collaborate with key stakeholders

Skills

• Experience with at least one other software than SAS (e.g., R, Python)
• Familiarity / experience with pharmacokinetic data and modeling and simulation datasets and analyses
• SAS programming experience including data steps, procedures, data manipulation, SAS/MACRO, SAS/GRAPH
• Ability to quickly and effectively learn new program techniques and data structures
• Knowledge in CDISC SDTM and ADaM standards
• An interest to advance career by investing in development activities and taking on tasks with increasing levels of challenge and responsibility

Education

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 2 years SAS programming experience in a clinical trial environment
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field