The Manager of Statistical Programming is a strategic role that guides a team of Statistical Programmers in the research and development of new pharmaceutical products, directly leading statistical programming activities for the Neuroscience group. 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; participate in development of SOPs.
- Provide oversight and mentoring to assigned Statistical Programmers/Analysts.
Minimum Qualifications:
- Bachelorβs in Statistics or Mathematics.
- 10+ years relevant experience (8+ with a Masters).
- Experience leading a team/project of statistical programmers.
- SAS programming experience related to drug development.
- In-depth understanding of CDISC standards.
- ADaM development and TLF generation experience (required).
Preferred Qualifications:
- Experience with regulatory filings.
Other Required Skills:
- Clear oral and written communication.
- Represent the Statistical Programming Organization on cross-functional teams.
- Accurately estimate effort for project programming activities.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees; eligible for long-term incentive programs.