The Director of Statistical Programming Standards & Infrastructure provides strategic leadership and oversight for the development, implementation, and maintenance of global statistical programming standards, tools, and infrastructure.
Requirements
- Define and execute the vision for statistical programming standards and infrastructure aligned with organizational goals.
- Establish governance for global programming standards, tools, and processes.
- Oversee creation, validation, and lifecycle management of global macros, standard programs, and reusable code libraries.
- Ensure adherence to SDLC principles for all programming tools and infrastructure components.
- Drive initiatives to enhance automation, scalability, and efficiency in programming workflows.
- Collaborate with IT to maintain robust, secure, and compliant programming environments.
- Ensure deliverables meet CDISC standards (SDTM, ADaM) and regulatory requirements (e.g., FDA, EMA).
- Oversee quality control processes for CRO deliverables and internal outputs, including datasets and TLFs.
- Partner with Biostatistics, Clinical Data Management, and other stakeholders to align standards and infrastructure with clinical development needs.
- Serve as subject matter expert for programming standards during audits and regulatory inspections.
- Lead and mentor a team of statistical programmers and standards specialists.
- Manage resource allocation, training and career development for team members.
- Identify emerging technologies and best practices to advance programming capabilities.
- Champion process improvements and standardization initiatives across the organization.
Benefits
- 401k plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Sales-based incentive plan (for field sales staff)
- Opportunity to purchase company stock
- Long-term incentives
- 15 accrued vacation days in the first year
- 17 paid holidays
- Up to 10 sick days throughout the calendar year
