Principal Statistician - Remote, United Kingdom - Quanticate

Description

Overview:

About the Company

Quanticate is the world leading data-focussed CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical input.

We need talented individuals to help us fulfil our customers' needs.

Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical programme, to small biotechs that are taking their first steps in clinical development

We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees.

Together we can help you build the career you want - developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.

Job Specification

Objectives:

• Provide high quality statistical support to clients, which conforms to current Quanticate and clientspecific standard operating procedures (SOPs) and processes, and to applicable regulatory requirements.
• Act as a lead point of contact with clients and accountable for enhancing customer satisfaction Lead crossfunction operational teams to ensure successful delivery of projects.

Procedures:

• Provide high quality statistical support to studies including design and analysis of studies, writing SAPs and selecting optimum statistical methods, statistical sections of study protocols, estimates of sample size, and statistical general consultancy including study design and conduct.
• Work as operational lead, ensuring tasks are appropriately delegated to members of the project team in line with the requirements of the project plan. Lead crossfunction operational teams to ensure successful delivery of projects.
• Monitor the work of the project team, and coordinate project delivery on time and within budget.
• Provide regulatory and submission support (PSUR, BB, DSMB, etc.)

Key Contacts/Relationships (Internal & External)

Internal

• Work closely with their line manager to review objectives, progress and development.
• Work closely with Senior and Principal Project Delivery Managers, Portfolio Managers/Director/VP, the Senior VP of Portfolio Delivery and Head of Programming and Statistics PMO allocated project teams, Senior Programming and Statistics staff, Group Managers, Clinicians and Medical Writers for the successful delivery of statistical activities.
• Work in Partnership with support functions including HR, Finance, IT and BD.
• Lead Statisticians, Senior Statisticians and Programmers assigned to projects to coordinate successful delivery of the required deliverables.

External

• Interact extensively with clients (including client PoC, statisticians, clinicians, medical writers, project managers) to lead the client relationship and successfully deliver statistical output, ensuring excellent customer care.
• Represent the company at external conferences and forums

Person Specification

Education:

• Qualified mínimally to MSc level in Statistics or equivalent.

And/or:

• Have relevant experience within the pharmaceutical industry or medical sector.
• Understand the principles and procedures of statistics.
• Good knowledge of SAS and experience with other statistical software.
• Proven ability to lead projects / Strong analytical and problemsolving skills.
• Significant experience in more than one study phase, with good understanding of all phases.

At Quanticate, our people are our focus, as we understand that they are the key to our success.

We strongly believe in work-life balance by offering flexible working arrangements, competitive salary, excellent benefits package and access to tools and computing systems including both SAS and R.