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Principal Biostatistician

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Date: Nov 16, 2020

Location: CA US CA

Company: Cytel Inc

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.

 

Cytel's Flexible Solutions Program (FSP) offers statistical programmers, biostatisticians and clinical data specialists amazing opportunities to work on client projects supporting clinical trial design and analysis.

As an experienced Biostatistician and leader on projects, you will support Cytel and one our clients in the Functional Service Provider (FSP) division on project and trial activities.  You should possess strong cross-functional communication, strategic thinking and operational leadership skills from a statistical perspective.

 

Contributions may include:

  • participation and leadership in project and program level activities in phase 2/3 as well as submission and approval activities
  • oversight as well as hands-on contributions for activities at project/program and study level
  • participation in clinical development planning, strategic evaluations, health authority related interactions etc.
  • participating in the development of study protocols, including participation in study design discussions and sample size calculations;
  • reviewing and developing statistical analysis plans (SAPs) at trial and project level, including analysis dataset and TLG specifications;
  • performing statistical analyses;
  • interpreting statistical results;
  • preparing clinical study reports, including integrated summaries for submissions (ISS/ISE), other documents for Health Authorities, Publication or exploratory purpose;
  • leading study activities when called upon;
  • perform QC and oversight of other third parties' contributions as appropriate
  • utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms and to provide strategic statistical input to teams;
  • serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
  • participate in special initiatives requiring statistical input as appropriate
  • being adaptable and flexible when priorities change

 

What we are looking for:

  • Master’s degree in statistics or a related discipline. PhD desirable.
  • 10+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. 
  • Project Lead Statistician experience for an indication or compound working with cross-functional teams;  experience leading regulatory submission and approval activities highly desired.
  • Strong in knowledge and implementation of statistical methods.
  • ISS/ISE experience
  • 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.
  • Strong understanding & implementation of CDISC requirement for regulatory submissions.
  • Adept in ADaM specifications generation and review and/QC of datasets.
  • Effective communicator: able to explain methodology and consequences of decisions in lay terms.
  • Great operational skills in leading team efforts from a statistical perspective; willingness to go the extra distance to get results, meet deadlines, etc.
  • Ability to be flexible when priorities change and deal with ambiguity

 

What’s 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 development
  • You will be part of an exciting new chapter in Cytel’s 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 implementation
  • 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 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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