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Principal Design Engineer • Romania
Ultima actualizare: acum 13 zile
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Principal Biostatistician
PRARomaniaÎn urmă cu peste 30 de zile
Descrierea postuluiPhD in statistics or biostatistics or related subjects and 5+ years of experience as a biostatistician in CRO or Pharmaceutical companies OR Masters degree in statistics or biostatistics or related subjects and 10+ years of experience as a biostatistician in CRO or Pharmaceutical companies Thorough knowledge of and experience with CDISC standards Thorough knowledge of and experience in Regulatory Previous experience in working on Phase 2 and 3 studies Previous experience in R programming, ESTIMANDS and adaptive designs Previous experience in writing of SAP Previous experience in creation of analysis for publications Strong Leadership and Communication skills Knowledge of ADAM and TFL programming
As a Principal Biostatistician you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing :
- Serve as the responsible biostatistician on clinical trials.
- Contribute to clinical study protocols.
- Develops Statistical Analysis Plans and / or performs senior quality review of statistical analysis plans
- Review and interpret results from simple to complex clinical studies.
- Provide relevant input in the development and review of CRFs.
- Performs lead review and sets up QC of TFL’s
- Perform critical review of derived datasets specifications and derived datasets (ADaM).
- Presentation of key results
- Contribute to clinical study reports.
- Review simple to complex randomization specifications and dummy randomization schemes.
- Oversee trials outsourced to Contract Research Organizations from a Biostatistics perspective
- Contributes to press releases and scientific papers.
You are :
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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