Biostatistics Sr Mgr
Amgen
2 days ago
Remote friendly (United States)
United States
Clinical Research and Development
Biostatistics Senior Manager
What You Will Do
- Independently lead sophisticated studies and projects in General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, Neuroscience), ensuring statistical aspects of clinical activities are robust and meet required standards.
- Inform and provide statistical guidance to clinical development, reimbursement, and medical affairs teams.
- Implement, manage, and support standards/technical quality/consistent approaches in strategy, study design, and statistical analysis.
- Plan and execute statistical contributions to protocols, Flash Memos, and Clinical Study Reports (CSRs).
- Provide input for clinical publications and regulatory filing documents.
- Lead all aspects of work performed by study statisticians.
- Perform statistical and exploratory analysis and develop conclusions/recommendations.
- Anticipate and communicate resource and quality challenges that may impact results/timelines.
- Stay current on innovative trial design and Amgen statistical policies/procedures/strategies.
- Contribute to process improvements and operational efficiencies.
Basic Qualifications
- Doctorate degree + 2 years Biostatistics experience OR
- Master’s degree + 6 years Biostatistics experience OR
- Bachelor’s degree + 8 years Biostatistics experience
Preferred Qualifications
- Doctorate in biostatics or statistics.
- 5+ years pharma/biotech statistical experience.
- Life cycle drug development experience; oncology experience.
- Leadership/motivation of multi-functional teams; strong negotiation/influence.
- Strong verbal/written communication; organizational skills; cross-cultural sensitivity.
- Statistical leadership and experience contributing to regulatory and reimbursement submissions.
- Strong theoretical/applied statistics and regulatory guideline knowledge.
- Experience working in globally dispersed teams.
Application Instructions
- Apply at careers.amgen.com. No application deadline; applications accepted until a sufficient number are received or a candidate is selected.
What You Will Do
- Independently lead sophisticated studies and projects in General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, Neuroscience), ensuring statistical aspects of clinical activities are robust and meet required standards.
- Inform and provide statistical guidance to clinical development, reimbursement, and medical affairs teams.
- Implement, manage, and support standards/technical quality/consistent approaches in strategy, study design, and statistical analysis.
- Plan and execute statistical contributions to protocols, Flash Memos, and Clinical Study Reports (CSRs).
- Provide input for clinical publications and regulatory filing documents.
- Lead all aspects of work performed by study statisticians.
- Perform statistical and exploratory analysis and develop conclusions/recommendations.
- Anticipate and communicate resource and quality challenges that may impact results/timelines.
- Stay current on innovative trial design and Amgen statistical policies/procedures/strategies.
- Contribute to process improvements and operational efficiencies.
Basic Qualifications
- Doctorate degree + 2 years Biostatistics experience OR
- Master’s degree + 6 years Biostatistics experience OR
- Bachelor’s degree + 8 years Biostatistics experience
Preferred Qualifications
- Doctorate in biostatics or statistics.
- 5+ years pharma/biotech statistical experience.
- Life cycle drug development experience; oncology experience.
- Leadership/motivation of multi-functional teams; strong negotiation/influence.
- Strong verbal/written communication; organizational skills; cross-cultural sensitivity.
- Statistical leadership and experience contributing to regulatory and reimbursement submissions.
- Strong theoretical/applied statistics and regulatory guideline knowledge.
- Experience working in globally dispersed teams.
Application Instructions
- Apply at careers.amgen.com. No application deadline; applications accepted until a sufficient number are received or a candidate is selected.