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, 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 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
- 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.
