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Job Description:

We are recruiting for a Senior Manager – Biostatistics for our location in High Wycombe

The Senior Manager, Biostatistics is a highly experienced individual with expert understanding of programming strategies, practices, methods, processes, technologies, industry standards, complex data structures, and analysis and reporting solutions. This position requires strong project and people leadership skills with the capability to effectively coordinate and oversee programming activities across teams in accordance with company and departmental processes and procedures.

You are responsible for formulating the Programming strategy across a large portfolio of one or more programs within a Disease area and/or Delivery Unit, with accountability for operational oversight and effective planning and execution of programming activities for their assigned portfolio. This position interfaces with program level Delivery Unit Leaders to provide regular status updates, identify and manage risks and issues, and ensures the appropriate use of escalation pathways to appropriate functional leaders as needed.

The Senior Manager provides functional area people and/or matrix leadership to departmental staff. The role is responsible for the recruitment, onboarding, performance management and development of people and future skills and technical knowledge expertise within their reporting line while building an inclusive and diverse working environment. You may also take on responsibilities of second line management (i.e. manager of managers).

In this role you play a critical role in the growth and development of C& SP and contribute to organizational effectiveness, transparency, and communication. Directly contributes to delivery of the J& J IM R& D portfolio through effective leadership and accountability of large or complex clinical development and strategic innovation of programs and projects.

In collaboration with Senior departmental leadership, the Senior Manager Biostatistics influences departmental effectiveness acting as a change agent to shape, drive and implement the departmental strategic vision.

This position develops strong and productive working relationships with key stakeholders within IDAR in addition to broader partners, external suppliers and/or industry groups.

Principal Responsibilities:

As Project Leader:

• Drives the strategy and planning, execution, and completion of all programming activities and deliverables within assigned scope ensuring quality, compliance standards, consistency, and efficiency.
• Proactively evaluates and manage resource demand, allocation, utilization, and delivery to meet current and future business needs. Ensure timely and effective maintenance of functional planning systems. May include forecasting related to potential in-licensing and acquisitions.
• Independently and effectively manages issue escalations, adopting appropriate escalation pathways.
• Collaborates with cross-functional and external partners on programming related deliverables for co-development programs and defining data integration strategy of the assigned programs/projects.
• Ensures training compliance and development of appropriate job skills for assigned personnel.
• Contributes to the development of functional vendor contracts and oversees of delivery in line with agreed milestones and scope of work, R& D business planning and budget estimates. Serves as the primary point of contact for sourcing providers and is responsible for establishing a strategic partnership.
• Drives the enhancement of functional, technical and/or scientific capabilities within C& SP and shares best practices.
• Leads programming related aspects of regulatory agency inspections and J& J internal audits ensuring real time inspection readiness for all programming deliverables.
• Provides input to submission strategy to regulatory agencies and ensures all programming deliverables are complete and compliant.

As People Leader:

• Responsible for attracting and retaining top talent, proactively managing performance, and actively supporting talent development and succession planning. Ensures organizational effectiveness, transparency, and communication.
• Provides mentorship and coaching to programming team members.
• Ensures training compliance and development of appropriate job skills for assigned personnel. Oversees their work allocation, providing coaching and guidance as necessary.
• Responsible for local administration and decision making associated with the management of assigned personnel.

As Matrix Leader:

• Accountable for actively identifying opportunities, evaluating, and driving solutions to enhance efficiency and knowledge-sharing across programs, value streams and the department.
• Serves as departmental resource in areas of process and technical expertise. Stays current with industry trends and policies related to Programming.
• Leads departmental innovation and process improvement projects and as required, may contribute programming expertise to cross functional projects/initiatives.
• Provides strategic direction within Delivery Unit initiatives and projects. Serves as a programming expert and influencer on internal and external (industry) work groups.

Clinical Programming Leader:

• Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards.

Education and Experience Requirements:

• Minimum Bachelor' s degree or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field
• Approx. 8+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
• In-depth knowledge of programming practices (including tools and processes) and regulatory guidelines (e.g., ICH-GCP)
• Project, risk, and team management and an established track record leading teams to successful outcomes.
• Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors.
• Excellent communication, leadership, influencing and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness adapting to rapidly changing organizations and business environments.
• Excellent written and verbal communications skills.
• Demonstrated experience managing the outsourcing or externalization programming activities in the clinical trials setting (e.g. working with CROs, academic institutions) is preferred.
• Expert CDISC Standards knowledge.
• Knowledge of data structures and relevant programming languages for data manipulation and reporting. Including SAS, R and Python.