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196 - Senior Biostatistician- Home or Office Based

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Date: May 11, 2019

Location: Waltham, MA, US Waltham, MA, US

Company: Cytel Inc

 

Cytel is shaping the future of drug development. As the world's largest independent clinical biostatistics research and development organization, we help leading pharmaceutical, biotech and medical device companies improve clinical success rates via optimal study design, effective data management, accurate statistical analysis and software. With operations across North America, Europe, and India, we are always on the lookout for passionate and talented people who share our mission of ensuring the clinical development of safe and effective medicines.

We are experiencing exponential growth on a global scale and expanding our FSP division and hiring Senior Biostatisticans, adept at utilizing advanced statistical methods, to lead or help drive one or more clinical studies, which may include, but is not limited to, Neuroscience, Psoriasis, Lupus and Arthritis-related studies. You will report to the Sr. Director, Cytel Services.

 
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.
  • 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

  Why Cytel?

  • 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 benefit’s 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.


Nearest Major Market: Waltham
Nearest Secondary Market: Boston

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