Statistician / Biostatistician

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Organisation
Keyrus
Locations

Lisbon, Portugal / Hybrid

Application Deadline

We are on a mission! Keyrus is a key player in consulting and technology specialised in Data & Analytics, AI & Machine Learning and Digital Transformation with clients in more than 20 countries in 4 continents.

For our Keyrus Life Science department we are currently looking for a Statistician / Biostatistician.

Responsibilities:
The Biostatistician we're looking for would be responsible for a whole study from design to execution for different study designs:

  • Use statistical methodology to establish study strategy (e.g. power modelling of different scenario, set up power).
  • Monitoring, set up mitigation plan to minimize risk of stat failure.
  • Provide input to protocol (design, objective, endpoint, randomization strategy, sample size, stat analysis).
  • Provide input to study set up (CRF review, randomization, DMP plan including specification for subset, important protocol deviation).
  • Develop Statistical Analysis Plan/Additional Analysis Request (involving sensitivity analysis to support robustness of result) and coordinate review.
  • Review the Tables Figures and Listings (TFL), to coordinate review with the stat analyst, to approve the TFL.
  • Do the QC of the statistical analysis methodology.
  • Validate study specific dataset & analysis programming specification.
  • Approve deviation from TFL format.
  • Propose Statistical Analysis Results conclusion.
  • Prepare answer to study specific stat question (e.g. inspection, regulatory question).

Profile:

  • You have 3 to 5 years’ experience in the field of Biostatistics in a pharmaceutical/ Contract Research Organization environment.
  • You are familiar with SAS software.
  • You have a strong knowledge of international scientific and regulatory guidelines (ICH, EMA, FDA, ...).
  • You have good interpersonal skills and a good global vision of the study process, which allows you to ensure an efficient interface with the project teams (project leader, data managers, medical writers,) and other external stakeholders (scientific experts, methodologists, etc.).
  • A good knowledge of CDISC standards (ADAM) is a plus.
  • Fluent in English
  • Must be a portuguese or european citizen or have a work permit for Portugal

What we offer at Keyrus Portugal:

  • Salary based on your skills and experience and according to the Data market practices.
  • Food ticket of €7.63 per day
  • Private Medical Insurance
  • 22 days of paid vacation
  • Training Program through KLX (Keyrus Learning Experience)

Why Keyrus?

Joining Keyrus means joining a market leader in the Data Intelligence field and an (inter)national player in Life Sciences, Management Consultancy and Digital Experience.

You will be part of a young and ever learning enterprise with an established international network of thought leading professionals driven by bridging the gap between innovation and business. You get the opportunity to meet specialised and professional consultants in a multicultural ecosystem.

Keyrus gives you the opportunity to showcase your talents and potential, to build up experience through working with our clients, with the opportunity to grow depending on your capabilities and affinities, in a great working and dynamic atmosphere.



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