Title: Principal / Associate Director, Statistical Programming

Location: King of Prussia, PA (Hybrid)

I am currently partnered with a leading pharmaceutical organization seeking an Individual Contributor, Statistical Programmer to lead programming activities across multiple clinical development programs spanning the full drug development lifecycle.

Key Responsibilities

• Lead and support statistical programming activities across multiple clinical studies and development programs.
• Develop, validate, review, and maintain SAS programs for data manipulation, analysis, reporting, and submission.
• Review external vendor deliverables (e.g., SDTM, ADaM, TLFs, Define.xml packages) to ensure accuracy, quality, and compliance with standards.
• Contribute to regulatory submissions, including NDA/BLA filings, integrated summaries (ISS/ISE), pooled analyses, and responses to health authorities.

Qualifications

• Bachelor's degree in Statistics, Mathematics, etc. (Masters Preferred)
• 8+ years of statistical programming experience within the pharmaceutical or biotechnology industry.
• Strong proficiency in SAS programming
• Deep understanding of regulatory guidelines (ICH, GCP) and industry standards.
• Extensive experience with CDISC standards, including SDTM and ADaM
• Prior involvement in regulatory submissions (NDA/BLA) and associated deliverables (e.g., Define.xml, validation processes) preferred.
• Strong communication, organizational, and cross-functional collaboration skills.
• Solid knowledge of statistical methodologies applied to clinical trial data.
• Demonstrated experience working with or overseeing external CRO partners.