Director, Statistical Programming, Clinical Schedules

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

This position may be based in either Rahway, NJ or Upper Gwynedd, PA

Primary Responsibilities:

• Direct the activities of clinical schedule managers whose predominant activities are the development and review of randomization and component ID schedules and associated documents and specifications for drug and vaccine programs across early and late phase drug development and the support related to provisioning for unblinded analyses
• Interact with cross functional our research lab division colleagues including, Statistics, Data Management, IT, Statistical Programming, Clinical Safety, IVRS & PRO Services, and Global Clinical Supply to evolve clinical schedule management, study blinding and unblinding capabilities to proactively address new trial designs and complexities, new study medication packaging designs, and data collection practices.
• Set the direction for clinical schedule management across all therapeutic areas for early and late phase clinical development, ensuring that schedule creation and unblinding preparation are executed efficiently, timely, and with high quality
• Manage staff resources and forecast support based on the book of business.
• Ensure appropriate and consistent application of SOPs, standards and quality and compliance measures
• Engage with cross functional stakeholders to identify areas for improvement and to solve business challenges. Establish strong partnerships with statistical and statistical programming stakeholders in BARDS LDS, EDS
• Provide technical guidance to employees and colleagues
• Engage with operational staff and partners globally
• Contribute to building and fostering group capability for the delivery of expertise, and behaviors required to deliver success on projects
• Hire appropriate, qualified staff
• Complete performance and employee development including coaching and mentoring
• Manage CSM training plans
• Lead and actively contribute to departmental strategic initiatives
• Represent Clinical Schedule Management at a leadership level. Be a visible contributor and decision maker.

Education:

• Bachelors or Master's (preferred) Degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering

Required Experience:

• BS plus a minimum of 12 years or MS with a minimum of 10 years working in an analysis and reporting environment.
• 2 years statistical programing 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 enga