Principal Biostatistician - Nueroscience (Remote)
Company: Cytel Inc
Location: High Point
Posted on: June 9, 2021
Cytel provides unrivaled
biostatistics and operations research knowledge to our customers in
the life sciences industries in the form of both software and
services. 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
Cytel’s FSP group is
growing and hiring well-rounded
Principal Biostatisticians to provide
statistical support, with a focus on ad-hoc work for clinical
studies, and some publications support, across a variety of
You will participate in
the development of study protocols including participation in study
design discussions and sample size calculations, and review CRFs
and data review guidelines.
- Develop statistical
analysis plans (SAPs) including analysis dataset and TLG
- Perform statistical
- Interpret statistical
- Help prepare clinical
study reports including integrated summaries for
What we need
- MS or PhD in a science
or industry-related discipline with five or more (8+) years working
on clinical trials.
- Experience in sample
size calculation, protocol concept development, protocol
development, SAP and preparing clinical study reports including
integrated summaries for submissions.
- Good SAS programming
skills for QCing critical outputs, Efficacy/Safety tables and
working closely with Programmers.
- Knowledge of R
programming a plus.
- Adept in ADaM
specifications, generation and QC of datasets.
- Submissions experience
- Experience working with
cross-functional teams, a Study Management Team (SMT) or similar
teams for different clients.
- Effective communicator:
able to explain methodology and consequences of decisions in lay
- Team player; willingness
to go the extra distance to get results, meet deadlines,
- Ability to be flexible
when priorities change and deal with ambiguity.
- Simulation and protocol
design experience strongly desired.
Cytel 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
Cytel’s 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
Keywords: Cytel Inc, High Point , Principal Biostatistician - Nueroscience (Remote), Other , High Point, North Carolina
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