Senior Statistical Management Leader
3 days ago
This is a high-level statistics management role within our organization.
Job Summary:We are seeking an experienced Senior Manager to lead our statistical programming team and drive the development, regulatory approval, and market acceptance of our products.
The ideal candidate will have expertise in designing, developing, and implementing technical solutions for integrating, analyzing, and reporting clinical data.
- Provide leadership and support to project teams and vendors, deploying programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements.
- Develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with predefined specifications and standards.
- Lead electronic submission preparation and review.
- Develop unambiguous and robust programming specifications.
- Review key planning documents to align with project objectives and ensure clarity and completeness of programming assumptions and requirements.
Responsibilities:
The successful candidate will be responsible for:
- Recruiting, managing, developing, evaluating, rewarding, motivating, and retaining up to 5 direct reports.
- Conducting objective setting, performance check-ins, and year-end discussions in compliance with organizational policies.
- Communicating proactively and effectively around issues and risks and contributing to remediation.
- Identifying, leading, and supporting opportunities to enhance processes and technology.
Requirements:
To succeed in this role, you will need:
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences.
- At least 9+ years of programming experience in industry, including support of significant regulatory filings.
- Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data.
Preferred Requirements:
Prior management experience supervising technical professionals is highly desirable.
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