Sr. Manager, Statistical Programming and Data Operations
Tasks
- Conduct ad hoc and post hoc clinical data analyses
- Coordinate process improvement for programming activities
- Coordinate vendor timelines budget and quality
- Create vendor RFPs and track deliverables
- Develop TLF shells and CDISC deliverables
- Manage statistical analysis plan and protocol document review
- Manage statistical programming vendor oversight
- Oversee TLFs and CDISC datasets for clinical trials
- Oversee TMFs with vendors
- Perform programming QC reviews
- Prepare CDISC data submission package
- Provide SAS programming for regulatory submissions
- Provide statistical programming input to biostatistics
- Support FDA inspection subject matter expertise
Perks/Benefits
- 401k match
- Employee referral awards
- HSA FSA programs
- Healthcare benefits
- Life and disability insurance
- Paid time off
- Tuition assistance
- Wellbeing and worklife programs
Skills/Tech-stack
CDISC | Clinical trials | Data integration | ICH E9 | ICH Guidelines | Microsoft Excel | Microsoft Outlook | Microsoft PowerPoint | Microsoft Word | R | Regulatory Submissions | Requests for Proposal | SAS | SAS LSAF | TLF | TMF
Education
Regions
Countries
States
Cities
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