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903 - Senior Biostatistician- Home or Office Based

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Date: Jun 29, 2019

Location: King of Prussia, PA, US

Company: Cytel Inc

As a leader in next generation, data-driven pharmaceutical services, Cytel is shaping the future of drug development.  We deliver to the market innovative analytical software for statistical analysis and simulation, best-in-class data science analytics services and high-end impact consulting.  Our culture is inclusive, collaborative and results-driven with a shared commitment to quality. With operations across North America, Europe, and India, Cytel hires passionate and talented people who share its mission of ensuring the clinical development of safe and effective medicines.

 

We are experiencing exponential growth on a global scale and hiring Senior Biostatisticians to lead or help drive one or more clinical studies, across a variety of therapeutic areas in our FSP division.  You will report to the Senior Director, Biostatistics.

 

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

 

How you will contribute:

 

  • provide input into the study design, efficacy and safety parameters and the planned statistical analyses
  • perform the sample size calculations
  • help prepare / review clinical study reports, and provide input on interpretation of results  and integrated summaries for submissions
  • respond to requests for the randomization schedule  
  • review data management related documents and evaluate the quality of the database  
  • author or review Statistical Analysis Plans (SAPs)  
  • coordinate with other biostatisticians and statistical programmers to prepare the statistical analyses
  • participate in data review/evaluation meetings and other study-related meetings and activities
  • contribute and review abstracts, posters, presentations and manuscripts for publication and ensure accuracy of all biostatistical aspects of such documents
  • other duties may be assigned

 

What you offer:

·       Master’s degree in statistics or a related discipline. PhD strongly desired.

·       3-5 years in supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.

·       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 methods.

·       Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.

·       Strong knowledge of ICH guidelines.

·       Solid understanding & implementation of CDISC requirement for regulatory submissions.

·       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 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

Meaningful Work, Collaborative Culture, Stimulating Challenges

  • Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry.
  • In addition to a competitive compensation, we offer an excellent benefits package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us!
  • Work with respected experts and thought leaders in the fields of biostatistics and statistical programming.

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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