Director, Statistical Programming
Tasks
- Collaborate with clinical operations data management drug safety regulatory project management
- Develop maintain data review and reporting tools
- Ensure implementation of company data standards and industry submission standards
- Ensure project milestones and timely analysis reporting
- Implement project standards and programming project management
- Lead statistical programming for multiple studies
- Manage programming deliverables through regulatory submission
- Provide leadership on programming priorities and communication
- Provide technical input to statistical documents
- Serve as programming representative in multidisciplinary study teams
Perks/Benefits
- Employee stock purchase plan
- Employee wellbeing benefits
- Fitness reimbursement
- Generous vacation time
- Long-term incentive
- Professional development plans
- Public holidays
- Remote work
- Tuition sponsoring
- Volunteer days
Skills/Tech-stack
ADaM | CDISC | Clinical Trial Programming | Clinical trial | Controlled Terminology | Data Standards | Define-XML | ECTD | R | Regulatory Submissions | Reviewer-Guide | S-Plus | SAS | SDTM | Vendor management
Education
N/A
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