Senior Manager Statistical Programmer Oncology

Senior Managers of Statistical Programming provide comprehensive programming expertise to clinical project teams to lead statistical programming teams and support the development, regulatory approval and market acceptance of Company's products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Senior Managers develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams. Senior Managers of Statistical Programming also support and lead improvement initiatives. They proactively plan, implement, and identify issues / risks and provide remediation strategies to facilitate decision making. Senior Managers also lead and support the change management process (e.g. communication, training, stakeholder engagement). This position may include functional management responsibilities. In this role, Senior Managers of Statistical Programming are responsible for managing employees : set objectives, manage performance, and provide meaningful coaching and feedback. They also support the evaluation and recruitment of potential employees.

Direct Reports

Vendor Oversight

Key Business

Partners Potential to manage up to 5 Statistical Programmers in addition to contractors and leased workers. Yes Internal / External stakeholders, project team members, vendors

Key

Responsibilities

Project Responsibilities :

• Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices
• Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards
• Leads / Supports the electronic submission preparation and review
• Develops unambiguous and robust programming specifications (e.g. ADaM specifications)
• Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities
• Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities :
• Identifies, leads, and supports opportunities to enhance processes and technology
• Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable) :
• Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS
• Conducts objective setting, performance check-ins, and year-end discussions in compliance with Company's policies; aligns objectives, feedback and performance evaluation with manager
• Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements
• Communicates with manager regarding promotions, performance concerns, and retention risks
• Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results

Skills,

knowledge, and

experience Minimum Requirements :