Manager - Statistical Programming (Hybrid)

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

Responsibilities:
- Lead statistical programming activities for a compound/indication or therapeutic area in early development.
- Lead a team of statistical programmers and manage resource planning for assigned staff.
- Ensure timely deliverables, quality processes, and consistency within projects.
- Develop and oversee SAS programs for ADaM data sets following CDISC standards.
- Develop and oversee SAS programs for Tables, Listings, and Figures.
- Ensure consistency of ADaM data sets for individual studies and integrated data.
- Create documentation for regulatory filings (reviewer guides and data definition documents).
- Lead development of standard SAS Macros and participate in development of standard operating procedures.
- Provide oversight and mentoring to Statistical Programmers/Analysts.

Qualifications:
- Bachelors in Statistics or Mathematics.
- 10+ years relevant experience (8+ with a Masters).
- Previous experience leading a team/project of statistical programmers.
- 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:
- Clear oral and written communication.
- Ability to represent the Statistical Programming Organization in cross-functional teams.
- Ability to estimate effort for project-related programming activities.