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Senior Biostatistician
2 months ago
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 compliance with regulatory requirements.
- 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, providing guidance and support in client project support.
- Ensure that statistical personnel follow standard operating procedures, maintaining data integrity and quality.
- 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.
- 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 ability to prioritize tasks and manage multiple projects.
- Excellent interpersonal and communication skills, with ability to work effectively with cross-functional teams and clients.
This job description does not 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.
WuXi AppTec is an equal opportunity employer and welcomes applications from diverse candidates. 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.
