Principal Statistician II at WuXi AppTec in San Diego, CA

Overview

The primary responsibilities of this position are to provide statistical consulting to clients in the biotech/pharmaceutical industry in their drug development programs with a focus on protocol/study design, analysis planning, regulatory submission strategies, regulatory communication, and assist with business proposals.

Responsibilities

• Provide statistical consulting to clinical study design
• Review study protocols and write statistical sections
• Conduct sample size and power calculations
• Propose randomization methods and designs
• Lead regulatory submission strategy planning for statistics function
• Identify issues, and provide solutions to clinical operation and data management for issues that potentially impact data analyses
• Review and provide comments to statistical analysis plans that are written by the 3rd party
• Develop statistical analysis plans, both for individual studies and integrated analyses for regulatory submissions
• Write statistical reports for results interpretation, both for individual studies and integrated analyses for regulatory submissions, if needed
• Prepare statistical sections of clinical study reports if needed
• Participate in clinical results interpretation meetings, both for individual studies and integrated analyses for regulatory submissions
• Work with medical writers to assist with clinical study reports and ISS/ISE reports preparation
• Review clinical study reports and other regulatory submission documents
• Participate in regulatory communication
• Lead statistical methodology research and stay current on statistical methodology and drug development
• Mentor junior statisticians in their support of client projects
• Ensure that statistical personnel follow the standard operating procedures
• Assist with preparation of business proposals

Qualifications

Education and Experience

• Master’s degree in Statistics, Biostatistics, or related degree, with 8-12 years or Doctoral degree with 6-10 years of relevant experience in a health sciences research institute or the pharmaceutical/biotech industry
• Direct participation in design, planning, conduct, analyses, and reporting of clinical trials
• Direct participation in regulatory submission activities

Skills

• Deep understanding statistical concepts and methodology related to clinical trials and drug development
• Comprehensive knowledge on regulatory guidelines
• Excellent organizational and project management skills
• Excellent interpersonal and communication skills