Senior Biostatistician

3 days ago

San Diego, California, United States WuXi AppTec Full time
Job Summary

We are seeking a highly skilled Senior Biostatistician to join our team at WuXi AppTec. As a key member of our statistical consulting group, you will provide expert statistical guidance to clients in the biotech/pharmaceutical industry, focusing on protocol/study design, analysis planning, and regulatory submission strategies.

Key Responsibilities
  • Provide statistical consulting to clinical study design, including protocol development and statistical analysis planning.
  • Review and write statistical sections of study protocols, ensuring compliance with regulatory guidelines.
  • Conduct sample size and power calculations to ensure study feasibility and reliability.
  • Develop and propose randomization methods and designs to optimize study outcomes.
  • Lead the development of regulatory submission strategies for statistics, ensuring timely and accurate submissions.
  • Identify and resolve issues that may impact data analysis, collaborating with clinical operations and data management teams.
  • Review and provide comments on statistical analysis plans prepared by third-party vendors.
  • Develop statistical analysis plans for individual studies and integrated analyses, ensuring regulatory compliance.
  • Write statistical reports for results interpretation, including individual studies and integrated analyses.
  • Prepare statistical sections of clinical study reports, as needed.
  • Participate in clinical results interpretation meetings, providing expert statistical guidance.
  • Collaborate with medical writers to develop clinical study reports and ISS/ISE reports.
  • Review clinical study reports and other regulatory submission documents, ensuring accuracy and compliance.
  • Mentor junior statisticians in their support of client projects, promoting professional growth and development.
  • Ensure that statistical personnel follow standard operating procedures, maintaining high-quality deliverables.
Qualifications
  • Master's or Doctoral degree in statistics or biostatistics.
  • 6-10 years of relevant experience in a health sciences research institute or the pharmaceutical/biotech industry, or 4-8 years with a Doctoral degree.
  • Direct participation in design, planning, conduct, analysis, and reporting of clinical trials.
  • Direct participation in regulatory submission activities.
Requirements
  • Deep understanding of statistical concepts and methodology related to clinical trials and drug development.
  • Comprehensive knowledge of regulatory guidelines, including FDA and ICH regulations.
  • Excellent organizational and project management skills, with the ability to prioritize multiple tasks and deadlines.
  • Excellent interpersonal and communication skills, with the ability to work effectively with cross-functional teams and clients.

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