Statistical Programming Manager Shockwave Medical
Overview
We seek a leader to own statistical programming for Circulatory Restoration studies and regulatory submissions. This role drives analysis datasets and ensures compliance with quality standards. The manager oversees teams and partners across departments. Unique opportunity to shape biotech innovation.
What You'll Do11
- 1Lead statistical programming activities for clinical studies and regulatory submissions
- 2Manage and develop statistical programmers and external resources
- 3Establish programming standards and quality control practices
- 4Provide technical oversight for analysis datasets and reporting outputs
- 5Review programming specifications and identify risks
- 6Partner with Biostatistics and Clinical teams to align deliverables
- 7Support regulatory submissions with accurate programming outputs
- 8Drive process improvement and automation in statistical programming
- 9Champion standardization across studies and programs
- 10Ensure compliance with GCP and GxP requirements
- 11Oversee internal and external program validation
Requirements11
- 1Bachelor’s degree in Statistics or related field
- 210+ years of statistical programming experience in medical device or pharma
- 3Advanced degree preferred
- 4Proven people management and project leadership
- 5Expertise in SAS programming and clinical data structures
- 6Familiarity with CDISC standards and GCP regulations
- 7Strong analytical reasoning and problem solving abilities
- 8Excellent communication and stakeholder management skills
- 9Ability to travel domestically and internationally
- 10Experience with clinical trial data and regulatory submissions
- 11Knowledge of automated programming and reproducible workflows
Salary Insight
$134 - $231k per year
Location
Required Skills
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