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Senior Biostatistician - Safety (FSP)


Cytel provides unrivalled 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, you will support Cytel and a client of our Functional Service Provider (FSP) division. You will be supporting safety activities for our client's projects, including but not limited to data pooling, Integrated Summary of Safety (ISS), Data Safety Update Reports (DSUR) etc.

Contributions May Include:

  • Work in close collaboration with our clients' safety and project teams, understand their needs and help develop appropriate safety pooling and reporting strategies
  • Take the lead or contribute to specifying pooled ADaM datasets, integrated analysis plans for ISS, DSUR, Investigator's Brochures and other safety related activities
  • Oversee and contribute to programming activities, validation and statistical QC.
  • Organize and plan teamwork for safety related statistical/programming requirements as appropriate.
  • If required, contribute to developing standards and templates for safety related activities.
  • Support trial level safety activities as required.
  • Contribute to answering health authority request, advisory activities, initiatives, publication, presentation, integration of new team members etc. as required.

What We Are Looking For

  • At least Master’s degree in statistics or a closely related discipline.
  • 7+ years supporting clinical trials and projects in the Pharmaceutical or Biotechnology industry
  • Experience with safety pooling, ISS and other project-level safety activities is required, ideally in a lead role from a sponsor's perspective. Experience writing ISS and/or dataset specifications highly desired
  • Strong knowledge of ADaM and safety reporting standards and regulatory requirements
  • Experience and technical capability to implement innovative methods for evaluating safety data is a plus
  • Ability to lead and plan team activities
  • Strong communicator and team worker
  • Strong skills using SAS
  • Good work ethics, results oriented

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 be working with safety specialist as well as with several cross-functional project and trial 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

How To Apply

To apply for this position, please click here.

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


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