Manager, Statistical Programming

Manager, Statistical Programming

Roles and Responsibilities

• Ensure the

  Statistical Programming department

  meets timelines, provides high-quality deliverables, complies with contractual project requirements and

  Standard Operating Procedures (SOPs)

  , and conducts projects within budget.
• Participate in the development of department SOPs and guidelines, promoting standardized processes to maximize efficiency.
• Responsible for

  staff development, training, and retention

  .
• Oversee the development of direct reports by setting goals, managing performance, evaluating training needs, and providing mentorship and coaching.
• Facilitate

  succession planning

  and maintain a Statistical Programming staff with diverse skills and competencies.
• Make recommendations for, and actively participate in, hiring, onboarding, transferring, and terminating staff.
• Maintain a strong working knowledge of clinical drug development,

  ICH

  , and other regulatory guidelines, serving as a department mentor.
• Develop and provide training for Statistical Programming associates.
• Prioritize activities across Statistical Programming projects and facilitate resolutions to project conflicts.
• Support or directly assign Statistical Programmers to projects to meet utilization goals and match skills to appropriate projects.
• Lead or support projects across multiple studies or programs.
• Support business development activities and participate in or lead departmental or corporate initiatives.

Skills Required

• Strong understanding of

  Statistical Programming

  principles and practices.
• Proven experience in

  project management

  within a statistical programming or clinical research environment.
• Knowledge of

  Standard Operating Procedures (SOPs)

  and guidelines.
• Experience in

  staff development, training, and performance management

  .
• Familiarity with

  clinical drug development, ICH

  , and other relevant regulatory guidelines.
• Excellent leadership, mentoring, and coaching abilities.
• Strong organizational and prioritization skills to manage activities across multiple projects.
• Exceptional communication and interpersonal skills to facilitate conflict resolution and collaborate effectively.