Principal Biostatistician

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ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Qualifications

Qualifications:
  • Master's degree in statistics or biostatistics required. PhD preferred.
  • Minimum of 8 years of biostatistical experience desired.
  • Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures, and good programming practices.
  • Demonstrates ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical trials.
  • Displays excellent communication skills with demonstrated leadership ability.ICON is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.


Responsibilities

Responsibilities:
  • Serves as the lead biostatistician on programs of studies or submissions, or on simple to complex individual studies.
  • Serves as an independent reporting statistician on data monitoring committees.
  • Develops statistical analysis plans and reporting specifications for simple to complex clinical studies.
  • Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies.
  • Performs senior review of TFLs and statistical analysis plans.
  • Provides significant input in the development and review of CRFs, edit specifications, and critical variable lists.
  • Performs lead review of TFLs and derived datasets for clinical studies.
  • Contributes to clinical study protocols and clinical study reports.
  • Reviews simple to complex randomization specifications and dummy randomization schemes.
  • Trains and mentors new or junior statisticians on statistical methods and ICON procedures.
  • Provides statistical training at monthly seminars.
  • Participates in bid defense meetings.


United States-Remote