Biostatistics Mgr
Amgen
4 months ago
Remote friendly (United States)
United States
Clinical Research and Development
Biostatistics Manager
What You Will Do
- Independently lead sophisticated studies in the General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience), ensuring statistical aspects of clinical activities meet required standards (robust and valid).
- Contribute to strategy development; defend statistical approaches; represent Global Biostatistical Science (GBS) by collaborating with multidisciplinary study teams.
Key activities include:
- Provide statistical contributions, statistical review, and quality control of Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), TLG shells, Submission Data File (SDF) specifications, study documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications.
- Complete statistical analysis of individual studies/projects; proficient in advanced R programming.
- Publish applied research in scientific journals/books and present statistical methodology at external scientific meetings.
- Stay current on statistics in drug development and contribute to scientific advances.
- Support statistical training and communication of Global Biostatistics responsibilities.
- Assist in reviewing Amgen Policies, SOPs, and controlled documents.
- Assist with study and systems audits.
- Participate in change/process improvement initiatives.
Basic Qualifications
- Doctorate degree OR
- Master’s degree + 3 years of Statistics/Biostatistics experience OR
- Bachelor’s degree + 5 years of Statistics/Biostatistics experience.
Preferred Qualifications
- Doctorate degree in statistics or biostatistics.
Application instructions
- Apply now; no application deadline—applications will continue until a sufficient number are received or a candidate is selected.
What You Will Do
- Independently lead sophisticated studies in the General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience), ensuring statistical aspects of clinical activities meet required standards (robust and valid).
- Contribute to strategy development; defend statistical approaches; represent Global Biostatistical Science (GBS) by collaborating with multidisciplinary study teams.
Key activities include:
- Provide statistical contributions, statistical review, and quality control of Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), TLG shells, Submission Data File (SDF) specifications, study documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications.
- Complete statistical analysis of individual studies/projects; proficient in advanced R programming.
- Publish applied research in scientific journals/books and present statistical methodology at external scientific meetings.
- Stay current on statistics in drug development and contribute to scientific advances.
- Support statistical training and communication of Global Biostatistics responsibilities.
- Assist in reviewing Amgen Policies, SOPs, and controlled documents.
- Assist with study and systems audits.
- Participate in change/process improvement initiatives.
Basic Qualifications
- Doctorate degree OR
- Master’s degree + 3 years of Statistics/Biostatistics experience OR
- Bachelor’s degree + 5 years of Statistics/Biostatistics experience.
Preferred Qualifications
- Doctorate degree in statistics or biostatistics.
Application instructions
- Apply now; no application deadline—applications will continue until a sufficient number are received or a candidate is selected.