Senior Manager, Statistical Programming

Role Summary

The Senior Manager Statistical Programming provides technical leadership and support to the project teams on all statistical programming matters according to the project strategies within therapeutic area(s). The incumbent manages the programming aspect of a project in collaboration with partnering functions, stakeholders, and external functional service providers for all programming deliverables from the single study through to regulatory approval, product launch, data monitoring boards, regulatory safety reports, and other requests. Oversees documentation and ensures consistent maintenance of code, logs, and output within a regulated environment. The incumbent will lead or participate in process and methodology development for department goals and SME topics. Maybe responsible for goal setting and performance management.

Responsibilities

• Manage and lead programming support within multiple studies/projects in various study activities to ensures timely and high-quality programming deliverables in assigned projects and areas. Lead and coordinate programming documentation including specifications, as appropriate, for multiple studies following programming standards and processes
• Demonstrate company values and act as a role model by demonstrating excellence, competence, collaboration, innovation, respect, ownership, and accountability
• Ensure the commitment and reinforcement of the roles and responsibilities of the statistical programming function
• Proactive communication with study and project teams to clarify requirements and specifications, guide direct reports or support programmers on assignment status
• Lead and support global regulatory authority submissions including preparing programming deliverable for submission and working closely with partnering functions to address health authority requests.
• Lead and manage department goals and SME topics
• May oversee development of direct reports by setting goals, managing performance, evaluating, and monitoring training needs, supporting development plans, mentoring, and coaching
• May participate in screening and interviewing candidates for contractor and permanent positions.

Qualifications

• MS (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 10+ (12+) years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry, including some project and people management experience.
• Advanced SAS programming skills in a clinical data environment with expertise in at least one, preferably multiple, therapeutic areas. Knowledge of other programming languages such as R, Python etc. is a plus.
• Understanding of pharmaceutical clinical development across multiple therapeutic areas (i.e. understanding of statistical concepts, techniques and clinical trial principles) and good knowledge of regulatory submissions and requirements
• Ability to work on global interdisciplinary teams. Good organizational, interpersonal, communication, and leadership skills. Establish and maintain effective working relationships with coworkers, managers, and clients
• Ability to effectively manage multiple tasks and projects
• Problem solving and innovative skills that demonstrate initiative and motivation
• Ability to influence others, mentor, and coach junior programmers to achieve results