Manager Statistical Programming

• Provide comprehensive programming leadership and support to clinical project teams, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices.
• Independently develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with requirements
• Ensure all deliverables are delivered with high-quality and according to timelines.
• Lead the electronic submission preparation and review
• Participate in internal/external audits and regulatory inspections as required.
• Follow applicable SOPs and relevant regulatory guidelines.
• Manage all study or non-study related statistical deliverables and resources allocation in a project(s).
• Keep project team members informed of programming progress and issues requiring their attention.
• Manage scheduling and time constraints across multiple projects at a time, set goals based on priorities from management, and adapt to timeline or priority changes by reorganizing daily workload.
• Negotiate and establish accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and complete project programming activities within timeframe allotted.
• Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for opinions of others.
• Display willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
• Effectively utilize current technologies and available tools for conducting the analyses.
• Ensure scientific integrity and animal welfare in all activities.
• Interact with global statisticians and other stakeholders.
• Create and maintain standard macros and applications to improve the efficiency of the department.
• Identify opportunities and proactively participate in and/or lead process/quality improvement initiatives, standardization, and other non-clinical initiatives.
• Develop wider knowledge of SAS and other relevant programming languages and processes within the GO, Biostatistics and Medical arenas.
• Contribute to the mentoring of other programmers, developing training courses, presenting training materials, providing feedback, or guiding new associates in process.
• Engage in knowledge share activities.
• Ensure scientific integrity and animal welfare in all activities.
• Train, mentor and coach global team members on Programming concepts.

People Leadership:

• Effectively recruit, lead, manage, develop, evaluate, reward, motivate and retain a group of programmers, on a day-to-day basis.
• Provide guidance to employees development plans and carry out performance review and feedback. Develop performance metrics for staff.
• Meet regularly with direct reports, focusing on project updates, development needs, issue resolution, and provide real-time coaching and feedback; hold staff accountable for quality and timeliness of programming activities; ensure staff is compliant with training requirements
• Communicate with management regarding promotions, performance concerns, and retention risks
• Provide programming expertise to the team
• Influence stakeholders by providing subject matter expertise on programming related items
• Identify opportunities to improve methodology and provide practical solutions for problems within area
• Ensure programming projects are delivered with high-quality and according to timelines.
• Contribute to cross-functional administrative or process improvement initiative(s)
• Contribute to department level initiatives.