2153 - Senior Biostatistician
Company: Cytel Inc
Location: Dearborn
Posted on: July 17, 2021
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Job Description:
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 development. We are experiencing exponential growth on a global
scale in our Project-Based Services (PBS) team. You will support
Phase I –IV clinical studies across a variety of therapeutic
areas. If you thrive working in a challenging, multi-tasking,
deadline-driven environment, you will fit in well with our team of
High Achievers! The Senior
Biostatistician provides statistical input into Phase I - IV
clinical trial development, performs the analysis of clinical trial
data, and provides statistical input into the reporting of clinical
trial results. Responsibilities include: providing statistical
input into protocol and case report form (CRF) development in all
therapeutic areas (e.g., trial design, sample size estimation,
randomization, statistical methods for protocols, edit checks for
clinical trial data); communicating with clients regarding study
protocol or statistical analysis issues; and writing detailed
statistical analysis plans including specifications for analysis
files, consistency checks, tables, and figures. 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.
The Senior
Biostatistician analyzes clinical trial data producing accurate
results representing the outcome of the trial, validates
statistical output, accurately interprets and clearly communicates
statistical results and concepts to non-statisticians. With the
medical writer, co-authors final integrated reports of clinical
trial data by writing thorough and clear statistical methods
sections and producing the statistical appendix for the final
report. The Senior Biostatistician also provides statistical output
as required for manuscripts and ensures that the results are
accurately interpreted in the publications.
The Senior
Biostatistician provides input into statistical standard operating
procedures (SOPs) and general standardization efforts (e.g.,
statistical methodology standards, standard data presentations) and
participates in interactions with regulatory agencies, as required.
In addition, the Senior Biostatistician collaborates effectively
with members of clinical trial implementation teams and with
Biometrics colleagues, and keeps abreast of new developments in
statistics, drug development, and regulatory guidance through
literature review and attendance at workshops and professional
meetings.
Qualifications
and Experience:
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
businesses/agencies.
Keywords: Cytel Inc, Dearborn , 2153 - Senior Biostatistician, Other , Dearborn, Michigan
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