Principal Biostatistician

Cytel Statistical Software And Services
Posted on

Type

Mid-level industry position

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

 

  • 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
  • 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

 

More Information

Posted on

Type

Mid-level industry position

United States