Senior Manager, Statistical Programming - Oncology Early Development

Responsibilities

• Leads the statistical programming activities for one or more compounds/indications or a therapeutic area.
• Manages a team of statistical programmers and the resource planning for their assigned projects.
• 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 the development of standard operating procedures.
• Manages, mentors and creates career development plans for assigned staff.
• Participates in the recruitment and selection of new staff.

Qualifications

• MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience.
• Minimum of 2 years 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.