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Principal Biostatistician (Early Drug Development)

Date: Apr 3, 2021

Location: Oviedo, O, US

Company: Cytel Inc

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.  At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

 

Cytel's Flexible Solutions Program (FSP) offers statistical programmers, biostatisticians and clinical data specialists amazing opportunities to work on client projects supporting clinical trial design and analysis.

As an experienced pharmaceutical statistician with strong technical skills you will support Cytel and a client of our Functional Service Provider (FSP) division. By working with the client's team of methodological experts you will provide input to their trial and project planning activities and other through Bayesian modelling and other methodologies

 

Contributions may include:

  • Work in close collaboration with our client's Statistical Innovation team
  • Understand and execute Bayesian models for trial design of various complexities (including adaptive designs)  - you do not have to be an advanced developer of methodologies but should be able to have a good dialogue with the expert and a good grasp of the methods). Support other methods and deliverables as required.
  • Use, adapt existing tools or develop new code as appropriate to run the models.
  • Communicate and work with trial and project statisticians as well as cross-functional team in order to customize the methods and models used to their needs and to provide input to their project and trial strategies.
  • Contribute to other drug development related activities (e.g. Health Authority interaction, submission documents, external advisory boards or steering committes, KOL interactions, publication etc.) as required
  • development and review of Statistical Analysis Plans (SAP), programming specifications etc. as appropriate; review of and input to other study or project related documents as appropriate
  • support and participation in communications with external experts, advisory boards, publication activities etc. as required
  • mentor more junior team members, contribute to Cytel or client non-project activities, participate in other required activities as appropriate

 

What we are looking for:

  • At least Master’s degree in statistics or a closely related discipline.
  • 5+ years supporting clinical trials and projects in the Pharmaceutical or Biotechnology industry
  • An interest in and a good grasp of innovative statistical methods and trial designs; experience using Bayesian modelling for trial designs.
  • Strong teamworker and communicator who can translate a project's needs into an appropriate implementation of the statistical model.
  • Good strategic thinking and ability to explain statistical considerations in lay terms. 
  • Strong skills with both SAS and R highly desired.
  • Results-oriented with good ethics

 

What’s in it for you:

  • You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
  • You will work with methodological experts as well as strategic teams
  • You will be part of an exciting new chapter in Cytel’s history with high growth and opportunities to progress within the company
  • Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
  • Work with and leverage the best and brightest minds in the industry

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.


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