Principal Biostatistician
Job Details
Full Job Description
At ICON, it’s our people that set us apart. Our diverse teams
enable us to become a better partner to our customers and help us to
fulfil our mission to advance and improve patients’
lives.
Our ‘Own It’ culture is driven by four key values that
bring us together as individuals and set us apart as an organisation:
Accountability & Delivery, Collaboration, Partnership and Integrity.
We want to be the Clinical Research Organisation that delivers
excellence to our clients and to patients at every touch-point. In
short, to be the partner of choice in drug
development.
That’s our vision. We’re driven by it. And we
need talented people who share it.
If you’re as driven as we are,
join us. You’ll be working in a dynamic and supportive environment,
with some of the brightest and the friendliest people in the sector,
and you’ll be helping shape an industry.
Principal
Biostatistician
Position Summary
This position will be
accountable for the leadership of the Biostatistics and Programming
activities of a program of studies of moderate complexity and/or of
high value with high impact for the organization. Also responsible for
planning, monitoring, organizing and reviewing activities of
biostatisticians and programmers working on the assigned program of
studies, ensuring individual studies and the overall program of
studies and integrated analyses are delivered on time, on budget to
required quality. Accountabilities also include maintenance of
consistency across studies.
Responsibilities:
•
Accountable for leading Biostatistics and Programming activities for a
program of studies of high complexity and/or of high value with high
impact.
• Bio statistical input into the design of the program,
Protocol input such as study design, sample size calculations and
patient randomization schemes and Statistical aspects of case report
form design
• Review project database structures, edit checks and
data management coding conventions
• Preparation of statistical
analysis plans including the definition of derived data, and the
design of statistical tables, figures, and data listings for clinical
summary reports
• Statistical analysis, Interpretation of data and
reporting of results.
• Writing of the statistical methods
sections of integrated study reports. Reviews draft integrated study
reports.
• Supports responses to regulatory questions on the
design of the program, and any labelling claims following
submission
• Participates in presentations at client and
investigator meetings.
• Preparation of biostatistics input to
ICON research proposals, and participates in proposal defense meetings
and makes presentations at marketing meetings with prospective
client.
• Ongoing coaching and mentorship of team
members.
Key Requirements:
• M.S. degree in statistics,
biostatistics, or related field with minimum of 9 years of relevant
experience (at least 8 of which must be in the pharmaceutical
industry); or Ph.D. in statistics, biostatistics, or related field
with minimum of 7 years of relevant experience (at least 6 of which
must be in the pharmaceutical industry).
• Experience with
oncology is required
• In-depth knowledge of study designs, and
statistical analysis applications in one or more therapeutic
areas.
• Excellent verbal and written communication skills as well
as interpersonal and project management skills
• Excellent
knowledge of a wide variety of principles, theories and concepts in
statistics and experimental design; must be able to apply them to the
development and analysis of clinical trials
• Excellent knowledge
of clinical trials methodology, regulatory requirements, statistics
and statistical software packages, including SAS are a must.
•
Experience leading a regulatory submission
• Must be able to
translate clients’ needs into statistical practice and educate clients
in the use of statistics.
Benefits of Working in
ICON:
Our success depends on the quality of our people. That’s why
we’ve made it a priority to build a culture that rewards high
performance and nurtures talent.
We offer very competitive
salary packages. And to keep them competitive, we regularly benchmark
them against our competitors. Our annual bonuses reflect delivery of
performance goals – both ours and yours.
We also provide a range
of health-related benefits to employees and their families and offer
competitive retirement plans – and related benefits such as life
assurance – so you can save and plan with confidence for the years
ahead.
But beyond the competitive salaries and comprehensive
benefits, you’ll benefit from an environment where you are encouraged
to fulfil your sense of purpose and drive lasting
change.
ICON 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, color, 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 through the form below.
#LI-AH13
Are you a current ICON Employee? Please click here to apply: link
Principal Biostatistician
U.K.
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