Director Statistical Programming, Randomization - Hybrid

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our Company's 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.

Our Quantitative Sciences team uses big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials. 

Education:

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

Required Experience

• BS plus 12-15 years or MS with 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 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

Preferred Skills:

• 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

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