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Principal Statistician I

San Diego, CA, United States

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

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 3 rd 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

Mentor junior statisticians in their support of client projects

Ensure that statistical personnel follow the standard operating procedures

Education

Master’s or Doctoral degree in statistics or biostatistics

Experience

Master’s degree with 6-10 years or Doctoral degree with 4-8 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

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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