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WuXi AppTec Inc
San Diego, CA, United States
Overview: 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. Responsibilities: Provide statistical consulting to clinical study design
Job Source: WuXi AppTec IncWuXi AppTec
san diego, ca
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 w
Job Source: WuXi AppTecWuXi AppTec
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
Job Source: WuXi AppTecWuXi AppTec
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
Job Source: WuXi AppTecWuXi AppTec
san diego, ca
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 w
Job Source: WuXi AppTecWuXi AppTec
San Diego, CA, United States
The primary responsibilities of this position are to provide leadership in planning and conducting data analyses in clinical studies, and participate in planning and data analyses for regulatory submission. • Provide statistical consulting to clinical study design • Review study protocols and write statistical sections • Conduct sample size and po
Job Source: WuXi AppTecWuXi AppTec
san diego, ca
The primary responsibilities of this position are to provide leadership in planning and conducting data analyses in clinical studies, and participate in planning and data analyses for regulatory submission. • Provide statistical consulting to clinical study design • Review study protocols and write statistical sections • Conduct sample size and po
Job Source: WuXi AppTecSpectrum
San Diego, CA, United States
Payroll Title: RSCH DATA ANL 3 Department: MEDICINE / Infectious Diseases Hiring Pay Scale $75,000 - $120,000 / Year Worksite: Remote Appointment Type: Career Appointment Percent: 100% Union: Uncovered Total Openings: 1 Work Schedule: Days, 8 hrs/day, Monday-Friday #124781 Senior Statistician - Remote
Job Source: SpectrumSan Diego/CA/US
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.
Email Alert for Principal Statistician I jobs in San Diego/CA/US
ⓘ There was an unexpected error processing your request.
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