Director, Statistical Programming
Skills
- Extensive SAS programming including macros and complex data steps
- Deep knowledge of CDISC standards (SDTM, ADaM) and DEFINE package creation
- Experience building and leading statistical programming teams
- Vendor management and oversight for statistical deliverables
- Integrated database creation and management for safety/efficacy analyses
- Strong project, resource and time management skills
- Clear written and verbal communication in remote environments
Responsibilities
- Manage and mentor a team of statistical programmers to deliver analysis datasets and reporting for clinical programs
- Lead statistical programming contributions to integrated data analyses and regulatory filing packages
- Develop and deliver SDTM and ADaM datasets, DEFINE packages, and integrated databases meeting CDISC standards
- Perform hands-on programming and independent validation using SAS to support analyses and vendor outputs
- Oversee and manage external statistical programming vendors for quality, timelines, and budget
- Collaborate with biostatisticians and cross-functional teams as a subject-matter-expert on data and analysis requirements
- Contribute to development and implementation of SOPs and processes governing statistical programming activities
Education
- Master's degree in Biostatistics, Statistics, Computer Science, or related field required
- Advanced degree or relevant continuing education in clinical data standards or regulatory submissions preferred
Benefits
- 100% paid medical, dental and vision for employees and dependents
- 401(k) program with company match and vesting after the first month
- Flexible time off
- Generous parental leave
- Potential additional compensation including bonus and equity
- Remote work flexibility and other fringe perks
Average salary estimate
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