Director Statistical Programming – Randomization

Director Statistical Programming – Randomization

Requirements

• Bachelors or Master’s (preferred) Degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering
• BS plus 12-15 years or MS with 10+ years working in an analysis and reporting environment
• 2 years statistical programming experience in a clinical trial environment
• 1 year of experience as a people manager leading a team
• 7+ years of project management experience in the development and execution of statistical analysis and reporting deliverables
• Prior people management experience with demonstrated ability to lead and develop people
• Expertise managing and forecasting team’s resources at the project and therapeutic area level
• Broad knowledge and demonstrated experience in developing clinical schedule management deliverables according to quality, compliance and timeliness requirements
• Expertise in randomization, clinical schedule specification and intersection with IRT and clinical supplies
• US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of submission deliverables
• A deep understanding of both Late Stage Development and Early Stage Development business needs and regulatory requirements
• Knowledge of regulatory agency requirements pertaining to maintaining study blind and clinical schedule management
• Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders; ability to engage key stakeholders
• Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
• Experience leading the activities of a programming team that includes functional sourcing partners, domestic contractors, and global resources; ability and interest to work across cultures and geographies

Responsibilities

No responsibilities provided.

Preferred Qualifications

• 3+ years’ experience managing a team of clinical schedule managers; completing people management responsibilities including both performance and talent management activities
• Demonstrated ability to handle change management; influence and drive strategies for implementation in operational area and collaborate with other leaders
• Demonstrated success in championing and driving proficiency and compliance with standard processes
• Strategic thinking – ability to turn strategy into tactical activities and operational objectives; Demonstrated experience leading strategic and departmental initiatives
• Familiarity and ability to comprehend statistical analysis methods and clinical data management concepts
• Ability to anticipate stakeholder and regulatory requirements
• Demonstrated ability to work across cultures and geographies
• Active in professional societies
• Experience in process improvement