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Study Lead Statistician
Remote, CA US
Posted: 01/06/2025
2025-01-06
2025-02-13
Employment Type:
Contract
Job Category: Biometrics
Job Number: 4183
Job Description
The primary role of this position is to provide statistical support for multiple clinical studies across all phases of clinical development. Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.
Responsibilities:
Qualifications:
Responsibilities:
- Perform all duties and responsibilities associated with the Study Lead Statistician role
- Attend Clinical Study Team meetings and provide all required statistical input related to strategy and operations of the clinical study.
- Plan and execute statistical contributions to Study Outlines, protocols, Statistical Analysis Plans (SAPs), Table, Listing and Figure (TLF) shells, Submission Data File specifications, other key-study related documentation, protocol deviations, Data Quality Review, and Clinical Study Reports (CSRs).
- Be familiar with statistical policy and strategy at Amgen.
- Stay abreast of latest developments in the field of statistics in drug development.
Qualifications:
- PhD in statistics or related field and at least 6 years of industry experience or MS in statistics or related field and at least 10 years of industry experience
- Comprehensive knowledge of clinical trials methodology, regulatory requirements, HEOR, and proficient SAS programming skills and experience with other statistical software packages. Ability to contribute strategically
- Proficient in Microsoft Office
- Professional, proactive demeanor
- Excellent written and verbal communication skills
- Experience with people management and development of staff
- Excellent interpersonal and project management skills
- Able to collaborate effectively with internal and external study management teams to meet project timelines
- Must be solution-oriented and willing to educate study team members in appropriate interpretation of designs and results