Senior Manager, Statistical Programming - Oncology Early Development

Senior Manager, Statistical Programming

Responsibilities:
- Lead statistical programming activities for one or more compounds/indications or a therapeutic area.
- Manage a team of statistical programmers and resource planning for assigned projects.
- Ensure timely deliverables, follow quality processes, and maintain consistency within projects.
- Develop and oversee SAS programs to create ADaM datasets following CDISC standards.
- Develop and oversee SAS programs to create Tables, Listings, and Figures.
- Ensure consistency of ADaM datasets for individual studies and integrated data.
- Create documentation for regulatory filings, including reviewer guides and data definition documents.
- Lead development of standard SAS macros and standard operating procedures.
- Manage, mentor, and create career development plans; participate in recruitment and selection.
- Perform hands-on programming to validate analysis datasets and TLFs delivered by CRO; support in-house studies.
- Oversee statistical programming tasks delivered by CROs for Oncology Early Development clinical projects.

Qualifications:
- MS in Statistics, Computer Science, or related field with 9+ years relevant experience; or BS with 11+ years relevant experience.
- Minimum 2 years experience leading a team of statistical programmers.
- In-depth understanding of SAS programming for drug development.
- In-depth understanding of CDISC standards.
- In-depth understanding of drug development process, including experience with regulatory filings.
- Ability to communicate clearly (oral and written) and represent the Statistical Programming organization in cross-functional teams.
- Ability to estimate effort for project-related programming activities.

Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible to participate in long-term incentive programs.