Principal / Project Lead statistician

Location St. Germans
Discipline: Biometrics
Job type: Permanent
Salary: £65000 to £85000
Contact name: Ashley Clarke

Contact email: ashley.clarke@rbwconsulting.com
Contact phone: 01293 584 300
Job ref: 22602
Published: 10 days ago
Expiry date: 23 December 2021

RBW consulting is currently recruiting for a Senior or Principal Statistician on a permanent basis working remotely in either the UK, Belgium or Germany.

The successful candidate will join a global biopharmaceutical company who strive to make the lives of people living with severe diseases that much more manageable. They continue to grow and keep their focus on the people they helping as their core value. They endeavour to deliver modern medicines and solutions that improve lives, whilst still being mindful of value.   

Due to continuing growth, I am seeking additional innovative minds to join my clients Statistical Programming department to help shape the future.

You will be given access to cutting-edge in-house technology, allowing you to work on global projects across a variety of therapeutic areas. You will be able to progress your career in the direction you choose to go and will encourage and mentor you along the way.

 

Job Overview

  • Provide strategic input into the translational development from pre-clinical to clinical for gene therapy
  • Lead statistics from design through to reporting within Gene Therapy, producing trial design and analysis
  • Represent Statistics on the clinical team, early mission team and at governance meetings.
  • Drive the use of both internal and external data to support choice of endpoint, trial designs, simulations and decision rules
  • Ensure studies are designed, data analysed, and results presented to enable evidence-based decision making
  • Applies statistical principles to provide strategic solutions to an array of challenging problems within gene therapy developments should they arise
  • Provide design expertise, statistical modelling, simulations and synthesis of external data

 

Responsibilities:

  • Lead the statistical input to the project development team, driving innovation and ensuring commitment to quality standards, processes and efficient delivery
  • Foster and encourage a culture of innovation, and act as a role model to others in actively owning and driving the pragmatic use of innovative methods where appropriate
  • Provide strategic statistical input into the Project supporting the development of the Target Profile, Quantitative Plan and SSI Functional Plan
  • Lead and manage statistical delivery of the projects, ensuring that a comprehensive assessment of the statistical approaches required to address agreed development objectives is defined. Liaise with specialist SSI groups as appropriate, including pre-clinical, CESI (Centre of Excellence and statistical innovation) and?Predictive Analytics.
  • Develop close collaboration with the project lead programmer and other members of SSI where relevant, ensuring the required capabilities are assigned to deliver against the SSI support to the project to agreed timelines and with quality
  • Ensure appropriate oversight of Strategic Partners and external vendors
  • Help establish and actively contribute to a Project Lead Forum to share learnings across statistics, programming and other projects and ensure SSI project statistical strategies are embedded
  • Ensure SSI standards are applied across the projects consistently working with the Standards Management team to develop any necessary new standards for the Project.
  • Work collaboratively with SSI Early or Late Development Partnering Leads (as appropriate) to ensure issues and learnings are shared to further develop both the partnership and individuals ?
  • Represent SSI as an active member of various project governance boards
  • Collaborating with statisticians, programmers and clinical/medical leads to develop and implement statistical approaches to improve data-driven decision making, to drive strategies to stakeholders for integration into critical business decisions
  • Champion and act as interface with Patient Value Units and project teams to drive data mining approaches as part of the New Development Paradigm to support development projects
  • Engage cross functionally to provide expert input into collaboration projects such as publications, clinical reports, safety reports and annual reports

Ideal Candidate

  • Master’s degree in Biostatistics or Statistics,
  • Early Development experience including trial design, simulations and Bayesian approaches
  • Gene Therapy experience both in early exploratory and regulatory interactions
  • Knowledge around Biomarkers can be used within Gene therapy
  • Proven influencer and collaborator in an early/late development team environment
  • Extensive experience in communicating complex quantitative ideas clearly with all levels of technical and non-technical personnel, in domestic and international environments
  • Proficient in SAS/R
  • Previous experience in a Project Lead Statistical role, ideally in a Pharma or CRO environment

 

To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.