Manager, Statistical Programming

Key Skills

Java Programming, Python Programming, C++, C Programming, SQL, Cloud computing, Scala Programming, Machine learning techniques, Data science techniques, MATLAB Programming, PyTorch, TensorFlow, R Programming

Job Description

The Manager of Statistical Programming is a strategic role which guides a team of Statistical Programmers in the research and development of new pharmaceutical products.

This role is directly responsible for leading the statistical programming activities for a compound/indication or therapeutic area in early development. The Manager of Statistical Programming must effectively interface 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.
• MS in Statistics, Computer Science or a related field with 8+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 10+ years of relevant experience.
• Previous experience leading a team of statistical programmers.
• In-depth understanding of SAS programming concepts and techniques related to drug development.
• In-depth understanding of CDISC Standards.
• In-depth understanding of the drug development process, including experience with regulatory filings.
• 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.

Significant Work Activities: N/A

Travel: No

Job Type: Experienced

Schedule: Full-time