Company: Cytel Software Corporation
Posted on: June 18, 2022
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.AsPrincipal Biostatistician, you will leverage your
knowledge and experience in applying advanced statistical methods
and SAS skills to lead or help drive one or more Phase I-IV trials,
with a focus Oncology studies. You will contribute by:
- participating in the development of study protocols, including
participation in study design discussions and sample size
- reviewing CRFs and data review guidelines; developing
statistical analysis plans (SAPs), including analysis dataset and
- performing statistical analyses;
- interpreting statistical results;
- preparing clinical study reports, including integrated
summaries for submissions (ISS/ISE);
- leading study activities when called upon;
- utilizing your strong communication skills to present and
explain methodology and consequences of decisions in lay
- serving as a team player, with a willingness to go the extra
distance to get results, meet deadlines, etc.;
- being adaptable and flexible when priorities change.What we are
- Masters degree in statistics or a related discipline. PhD
- 8-10 years supporting clinical trials in the Pharmaceutical or
Biotechnology industry. Experience working for a CRO strongly
- Experience in Early Development studesdesired.
- 3-5 years of Study Lead experience working with
- Experience in sample size calculation, protocol concept
development, protocol development, SAP and preparing clinical study
reports including integrated summaries for submissions.
- Knowledge and implementation of advanced statistical
- Good SAS programming skills for QCing critical outputs,
Efficacy/Safety tables and working closely with Programmers.
Knowledge of R programming a plus.
- Strong knowledge ofICH guidelines.
- Solidunderstanding & implementation of CDISC requirement for
- Adept in ADaM specifications generation and programmatic review
- Submissions experience (ISS/ISE) strongly desired.
- Effective communicator: able to explain methodology and
consequences of decisions in lay terms.
- Team player; willingness to go the extra distance to get
results, meet deadlines, etc.
- Ability to be flexible when priorities change and deal with
ambiguity.Whats 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
- You will be part of an exciting new chapter in Cytels history
with high growth and opportunities to progress in Senior and
Leadership positions within the company.
- Work in an environment designed for an entrepreneurial minded
person with a lot of energy, ideas and courage for their
- Work with and leverage the best and brightest minds in the
industry.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
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
Keywords: Cytel Software Corporation, Kenosha , Principal Biostatistician, Other , Kenosha, Wisconsin
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