Associate Director, Statistical Programming
Title: Principal / Associate Director, Statistical Programming
Location: King of Prussia, PA (Hybrid)
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.
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