Manager - Statistical Programming (Hybrid)

About the role

This strategic role guides a team of Statistical Programmers in the research and development of new pharmaceutical products. The Manager of Statistical Programming is directly responsible for leading the statistical programming activities for the Neuroscience group and interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations.

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 Master’s)
• 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

Preferred Qualifications

• Experience with regulatory filings

Other Required Skills

• Ability to communicate clearly both oral and written
• Ability to effectively represent the Statistical Programming Organization in cross functional teams
• Ability to accurately estimate effort required for project related programming activities