Sr. Manager - Statistical Programming, Central Services
Tasks
- Collaborate with biostatisticians and data management
- Deliver analysis outputs for clinical studies and submissions
- Develop statistical programming tools standards and best practices
- Drive process improvements and innovation
- Ensure regulatory compliant data outputs
- Mentor and guide team members
- Oversee integrated dataset development
- Prepare and review electronic submission packages
- Provide technical leadership for statistical programming
- Support clinical trial transparency and disclosure
- Support inspection readiness and regulatory query response
Perks/Benefits
- 401k company match
- Family support benefits
- Fitness centers
- Health and wellness programs
- Hybrid work
- Insurance benefits
- Paid time off
- Pension or retirement benefits
Skills/Tech-stack
ADaM | CDISC | Clinical trials | Compliance checks | Data Validation | Define-XML | ECTD | Integrated Analyses | Pinnacle 21 | Pooled ADaM | Python | R | Regulatory Submissions | SAS | SDTM
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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