Manager- Statistical Programming

Broad Purpose

Avance Clinical is a Contract Research Organisation which offers specialised services supporting drug

development for the pharmaceutical and biotechnology industry.

Manager, Statistical Programming is responsible for the oversight of statistical programming operations and

team, and for reporting to Associate Director, Statistical Programming.

Core Responsibilities

Ensure a high level of client service is delivered and maintained in terms of deliverables and timelines,

whilst also delivering projects within budget.

Ensure statistical programming team deliverables consistently meet study timelines, quality standards

and contractual requirements.

Implement effective tracking and reporting to monitor staff workload and optimize staff utilization.

Provide a strong, cohesive link between the Statistical Programming Team and Biometrics (i.e. Statistics

and Pharmacokinetics) and Data Teams ensuring clear and defined communication pathways are

established.

Report regularly to the Associate Director, Statistical Programming in respect to Statistical Programming

group operations, resourcing, system issues, project performance and potential project slippages.

Provide considered justification statements to the Associate Director, Statistical Programming relative to

resource expenditure.

Monitor projects against milestones and budget.

Provide leadership in issue resolution with external parties, i.e. clients and external vendors and auditors.

Identification and remediation of issues arising that may affect the planned completion of client projects

including provision of support, guidance and assistance (when necessary) to Statistical Programming staff

to meet project milestones.

Provide extensive technical and managerial leadership, including mentorship and training of direct

reports; delegate responsibilities appropriately with the target of continuously developing team

capabilities.

Participate in the development and refinement of global statistical programming standards, as well as

supporting best practices and process improvement initiatives across the department.

Facilitate communication between all project stakeholders and ensure that regular updates are provided

in accordance with each study plan.

Participate in client meetings and Audits as required.

Other duties as directed by Line Management or delegate in line with skills, experience and/or

qualifications.

Departmental Responsibilities

In consultation with stakeholders, initiate the development of team members via training, programming

process improvements.

Ensure there is ongoing quality review within the departments as required, including internal reviews of

documents and forms to ensure they are appropriate for use.

Ensure appropriate allocation of team resources to client programs to ensure timely delivery of activities,

monitor individual workloads and ensure staff keep task lists current.

Manage recruitment, training, human resource and performance management for the Statistical

Programming Team.

Quarterly review of staff training files to ensure compliance with Standard Operating Procedures (SOPs)

and to maintain staff development.

Monitor adherence to guidelines and policies.

Qualifications, Skills and Experience

Minimum 12 years experience in the pharmaceutical industry / CRO working in clinical project

management.

Proven experience in different phases and therapeutic areas of clinical trial programming.

Possess excellent interpersonal and communication skills.

Can build and maintain positive relationships with management, peers, and subordinates.

Ability to work independently or in a team environment as needed.

Display strong analytical and problem-solving skills.

If the above opportunity interests you then please e mail your CV to [HIDDEN TEXT]