Manager - Statistical Programming (Hybrid)

Responsibilities

• Leads the statistical programming activities for a compound/indication or therapeutic area in early development.
• Leads a team of statistical programmers and manages the resource planning for assigned staff.
• Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
• Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
• Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
• Ensures consistency of ADaM data sets for individual studies and integrated data.
• Creates documentation for regulatory filings including reviewers guides and data definition documents.
• Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
• Provides oversight and mentoring of assigned Statistical Programmers, Statistical Analysts and Senior Statistical Analysts.

Qualifications

• Bachelor's in Statistics or Mathematics
• 10+ years of relevant experience. (or 8+ with a Masters)
• Previous experience leading a team/project of statistical programmers.
• Experience with SAS programming concepts and techniques related to drug development.
• In-depth understanding of CDISC Standards.
• Experience with ADaM development and TLF generation is required.