Senior Program Manager, Biostatistics
Company: ICON Clinical Research
Location: Bismarck
Posted on: January 19, 2023
Job Description:
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.ICON has an exciting
opportunity for a Senior Program Manager, Biostatistics to join our
team.Location: (home-based OR office-based)
- United States
- CanadaOverview of the role:The Senior Program Manager,
Biostatistics will be accountable for the leadership of the
Biostatistics and Programming activities of a program of studies of
high 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, and maintain consistency across studies.
- Biostatistical 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 (SAP) 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 the
design of the program, and any labelling claims following
submission
- The program of studies will typically lead to a regulatory
submission and be for one of ICONs Strategic Clients.To be
successful, you will need:
- M.S. or Ph.D. degree in statistics, biostatistics, or related
field (required)
- 10+ years of relevant experience with M.S. OR 8+ years of
relevant experience with Ph.D. (with at least 6-8 years of
experience in the pharmaceutical industry)
- Excellent verbal and written communication skills
- In-depth knowledge of study designs, and statistical analysis
applications in one or more therapeutic areas
- Excellent knowledge of clinical trials methodology, regulatory
requirements, statistics and statistical software packages,
including SAS are a must
- Prior experience interacting with sponsor/clients
- Experience leading Phase II and/or Phase III studies
- Oncology experience is preferred, but not requiredBenefits of
Working in ICON:Our success depends on the knowledge, capabilities
and quality of our people. Thats 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.At 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.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, 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-REMOTE #LI-JW1
Keywords: ICON Clinical Research, Bismarck , Senior Program Manager, Biostatistics, Executive , Bismarck, North Dakota
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