Project Lead Statistician

Project Lead Statistician - Award Winning Pharma - UK / EU - Remote

Overview:
We have partnered with this award winning Global Pharma are currently searching for an experienced Statistician to join their successful Global Clinical Development, Statistics and Data Management team.

What you will be doing?

You will provide statistical leadership to clinical drug development and external opportunity evaluation to ensure appropriate statistical methodology is applied to the assigned project(s). You will also represent statistics within the Clinical Development Plan (CDP) team, to support other statisticians involved in the project, ensuring consistent approach across studies.

As well as this, you will ensure statistical activities of the assigned projects are planned/executed according to regulatory requirements, internal standards, project timelines, under budget control.

Main responsibilities:

• To provide scientifically rigorous statistical expertise to clinical development plans, study design statistical analysis, interpretation and communication of statistical results
• Responsible for quality and timelines of all statistical deliverables of the assigned projects / studies including review / approve key statistical vendor deliverables
• To share project related information to statistician(s) involved in the project and oversee their activities to ensure consistent approach across studies
• To provide statistical input to submission plan, to represent statistics in interacting with regulatory agencies and Health Technology Assessment (HTA) bodies
• To lead the preparation of all the statistical deliverables required by regulatory submission (ISS, ISE, data package) ensuring compliance with regulatory requirements
• To contribute to development of internal standards and to process definition / improvement, SOPs writing / review
• To contribute to internal initiatives, lessons learned and trainings
• To represent statistics for auditing / regulatory inspection
• To create and maintain collaborative relationship with external Statistical experts and groups

What can you bring to the company?

• PhD or MSc degree in Statistics
• A significant experience in statistics applied to clinical trials acquired within pharmaceutical companies or CROs
• Advanced understanding of drug development process and regulatory requirements
• Strong statistical methodology knowledge with application to drug development
• Strong experience in regulatory activity (submission preparation and interactions with authority in different geographical areas)
• Highly effective written, oral and interpersonal communication skills
• Leadership and ability to work in a matrix organization

What’s in it for you?

• Exceptional remuneration package
• Collaborative and inspirational working environment / atmosphere
• Ongoing training/development and career progression opportunities
• Friendly, team oriented company and work/life balance

What is the next step

Interested? Drop me a message or send your CV to aimee@warmanobrien.com receive more details surrounding this role and discuss this further