The Manager of Statistical Programming is a strategic role leading statistical programming activities for the Neuroscience group, interfacing 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; manage resource planning for assigned staff.
- Ensure timely deliverables, quality processes, and project consistency.
- Develop and oversee SAS programs for ADaM datasets (CDISC standards).
- Develop and oversee SAS programs for Tables, Listings, and Figures.
- Ensure ADaM consistency across individual studies and integrated data.
- Create documentation for regulatory filings (reviewers guides, data definition documents).
- Lead standard SAS Macro development; participate in SOP development.
- Provide oversight and mentoring for Statistical Programmers/Analysts.
Qualifications:
- Bachelors in Statistics or Mathematics.
- 10+ years relevant experience (or 8+ with a Masters).
- Prior experience leading a team/project of statistical programmers.
- SAS programming for drug development.
- In-depth understanding of CDISC standards.
- Experience with ADaM development and TLF generation (required).
Preferred:
- Experience with regulatory filings.
Other Required Skills:
- Clear oral and written communication.
- Represent the Statistical Programming organization in cross-functional teams.
- Accurately estimate effort for project programming activities.
Benefits (as stated):
- Paid time off; medical/dental/vision insurance; 401(k) (eligible employees).
- Long-term incentive program eligibility.