Senior Manager, Statistical Programming

Summary

Join AbbVie as a Senior Manager of Statistical Programming and lead statistical programming and analysis oversight for Oncology Early Development (OED) clinical projects conducted by CROs. Oversee several compounds/indications, ensuring data integrity and high-quality analysis for oncology clinical trials. Perform hands-on programming to validate analysis datasets and TLFs, support in-house studies, and manage statistical programmers. The role involves leading statistical programming activities, managing a team, ensuring timely deliverables, developing SAS programs, creating documentation for regulatory filings, and developing standard SAS Macros and SOPs. You will also mentor and develop staff and participate in recruitment. This position requires a strong background in SAS programming, CDISC standards, and drug development.

Requirements

• 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

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

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs