Cytel - USA & APAC-posted about 1 year ago
Full-time • Senior
Cambridge, MA

As a Senior Biostatistician at Cytel, you will play a crucial role in supporting or leading Phase I-IV clinical studies for a global pharmaceutical client. This position emphasizes collaboration, innovation, and the application of advanced statistical methods to drive clinical development forward. You will be responsible for providing statistical support, developing study protocols, and ensuring compliance with FDA regulations, all while working closely with various stakeholders to meet project goals.

  • Providing statistical support to clinical studies
  • 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 and interpreting statistical results
  • Preparing clinical study reports, including integrated summaries for submissions
  • Utilizing strong communication skills to present and explain methodology and consequences of decisions
  • Understanding and following FDA regulations affecting the reporting of clinical trial data
  • Contributing to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
  • Participating in the development of CRFs, edit check specifications, and data validation plans
  • Providing review and/or author data transfer specifications for external vendor data
  • Collaborating with internal and external functions to ensure meeting project timelines and goals
  • Providing review and/or author SOPs and/or Work Instructions related to statistical programming practices
  • Master's degree in statistics or a related discipline; Ph.D. strongly desired
  • 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry
  • Experience working for a CRO is strongly desired
  • Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions
  • Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers; knowledge of R programming is a plus
  • Solid understanding & implementation of CDISC requirements for regulatory submissions
  • Adept in ADaM specifications generation and QC of datasets
  • Ability to build strong external & internal relationships and motivate a regional or global team
  • Effective communicator: able to explain methodology and consequences of decisions in lay terms
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