Senior Biostatistician (FSP)
Company: Cytel Software Corporation
Location: Cleveland
Posted on: May 26, 2023
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Job Description:
At Cytel, we work hard to create successful careers with
significant professional growth for our employees, as a result of
which they work hard to make Cytel successful. Cytel is a place
where talent, experience and integrity come together to advance the
state of clinical development. Cytel''s Functional Service Provider
(FSP) department offers statistical programmers, biostatisticians
and clinical data specialists amazing opportunities to work on
client projects.As a Senior Biostatistician you will support Cytel
and a client of our Functional Service Provider (FSP) division''s
Full Development activities. You should have experience with
clinical trials and a solid background in statistics. Contributions
may include:Participation in clinical trial activities (mostly
phase 2-4) as part of a cross-function teamLead or support clinical
trial activities from a statistician perspective Develop,
contribute to and review Statistical Analysis Plans (SAPs) and
provide specifications for the programming activitiesOversee
programming activities (mostly using SAS), including hands-on
programming contributions and QC of programmers'' (and other
statisticians'') deliverablesContribute to project level activities
(e.g. pooling specification, ISS/E planning, submission and Health
Authority Questions) as appropriateSupport reporting of clinical
trial activities and communication with clinical team
members.Provide statistical input to clinical study protocol
development as requiredReview and give input to other documents
(e.g. clinical study report) as appropriateContribute to other
activities, e.g. adhoc requests, publication related analyses etc.
as appropriate.What we are looking for:Masters degree in statistics
or a related discipline. At least 2-4 years'' experience supporting
clinical trials and projects as a statistician in a pharmaceutical
company or in an FSP model at a CRO Experience with regulatory
submission activities, clinical summaries etc. is a plusSolid
technical/methodological skillSolid experience writing Statistical
Analysis Plans and overseeing TFL production from a statistical
perspectiveStrong SAS skillsFamiliarity with CDISC specifications,
in particular ADaM and reportingGood operational and communication
skillsConstructive collaborative attitude Results-oriented with
good ethicsWhats in it for you:You will have the opportunity to
play an integral role helping our clients and the industry shape
the future of drug developmentYou will be part of an exciting new
chapter in Cytels history with high growth and opportunities to
progress within the companyWork in an environment designed for an
entrepreneurial minded person with a lot of energy, ideas and
courage for their implementationWork with and leverage the best and
brightest minds in the industryLI-CR1Cytel Inc. is an Equal
Employment / Affirmative Action Employer. Applicants are considered
for all positions without regard to race, color, religion, sex,
national origin, age, veteran status, disability, sexual
orientation, gender identity or expression, or any other
characteristics protected by law.Cytel does not accept referrals
from employment businesses and/or employment agencies in respect of
the vacancies posted on this site. All employment
businesses/agencies are required to contact Cytels human resources
department to obtain prior written authorization before referring
any candidates to Cytel. The obtaining of prior written
authorization is a condition precedent to any agreement (verbal or
written) between the employment business/ agency and Cytel. In the
absence of such written authorization being obtained any actions
undertaken by the employment business/agency shall be deemed to
have been performed without the consent or contractual agreement of
Cytel. Cytel shall therefore not be liable for any fees arising
from such actions or any fees arising from any referrals by
employment businesses/agencies.RequiredPreferredJob
IndustriesCustomer Service
Keywords: Cytel Software Corporation, Cleveland , Senior Biostatistician (FSP), Other , Cleveland, Ohio
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