Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use., As a Principal Biostatistician, your responsibilities will include:

• participating in the development of study protocols, including participation in study design discussions and sample size calculations;
• reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
• performing statistical analyses;
• interpreting statistical results;
• preparing and reviewing study reports;
• leading study activities when called upon;
• utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
• serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
• being adaptable and flexible when priorities change.
  
  As a Principal Biostatistician, you will leverage your knowledge and experience in applying advanced statistical methods and SAS skills to lead or help drive one or more post-marketing studies., Here at Cytel we want our employees to succeed, and we enable this success through consistent training, development and support. To be successful in this position you will have:
• Master's degree in statistics or a related discipline. PhD strongly desired.
• 8-10 years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
• 3-5 years of Study Lead experience working with cross-functional teams.
• Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
• Experience with Real-World Data/RWD (especially OMOP data) required.
• Experience with oncology clinical studies required.
• 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 programmatic review of datasets.
• Submissions experience (ISS/ISE) strongly desired.
• 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.