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890 - Senior Biostatistician

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Date: Feb 11, 2019

Location: King of Prussia, PA, US

Company: Cytel Inc

Cytel’s FSP group is growing and hiring well-rounded Sr. Biostatisticians to provide statistical support, with a focus on ad-hoc work for clinical studies, and some publications support, across a variety of therapeutic areas.

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.

 

Additionally, you will:

  • develop statistical analysis plans (SAPs) including analysis dataset and TLG specifications
  • perform statistical analyses
  • interpret statistical results
  • help prepare clinical study reports including integrated summaries for submissions

 

This is a home-based position with the option to work at our King of Prussia, PA or Waltham, MA office locations.

 

What we need from you:

·   MS or PhD in a science or industry-related discipline with five or more (5+) 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 strongly desired.

·   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 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.

·   Simulation and protocol design experience strongly desired.

 

Cytel offers a competitive salary, with an annual bonus incentive, excellent benefit’s package and the opportunity to GROW with us!

 

About us:

At Cytel we believe the clinical development of safe and effective medicines is crucial for human welfare. Our mission is to improve success rates in the clinical development of safe and effective medicines which are crucial for human welfare, via the optimal design, effective implementation and accurate data management of clinical trials. We believe that if you don’t get the trial design right, nothing else matters; and that every sponsor should evaluate the option of an adaptive approach. While Cytel may be best known for our pioneering work in adaptive approaches, our growing clinical research customers rely on Cytel strategic consulting, statistical programming and end-to-end data management expertise. As the world's largest biometrics CRO, all the major pharmaceutical, biotech and medical device companies are our customers along with scores of specialty and emerging sponsor companies. We also count among our customers and research partners the leaders in academia, at medical institutions and international regulatory agencies. www.cytel.com

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 businesses/agencies.


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