Biostatistics Sr Mgr
Amgen
5 days ago
Remote friendly (United States)
United States
Clinical Research and Development
Biostatistics Senior Manager
What You Will Do
- Provide sound statistical guidance to clinical development, reimbursement, and medical affairs teams.
- Implement/manage standards and 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 impacting results/timelines.
- Apply regulatory guidelines in drug development.
- Stay current on innovative trial design and Amgen statistical policies/procedures/strategies.
- Contribute to process improvements and operational efficiencies.
Basic Qualifications
- Doctorate in Statistics/Biostatistics (or related, high statistical content) + 2+ years biostatistics OR
- Master’s in Statistics/Biostatistics (or related) + 4+ years OR
- Bachelor’s in Statistics/Biostatistics (or related) + 6+ years OR
- Associate’s degree + 10 years OR High school diploma/GED + 12 years.
Preferred Qualifications
- Doctorate in biostatistics/statistics.
- 5+ years pharma/biotech statistical experience.
- Life cycle drug development; cardiovascular experience.
- Leadership of multi-functional teams; strong communication and cross-cultural sensitivity.
- Statistical leadership for regulatory and reimbursement submissions.
- Strong theoretical/applied statistics and regulatory guideline knowledge.
- Experience in globally dispersed, cross-cultural teams.
Benefits (as stated)
- Retirement and Savings Plan; medical/dental/vision; life and disability insurance; flexible spending accounts; discretionary annual bonus (or sales incentive); stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com. No application deadline; applications continue until sufficient candidates are received or selected.
What You Will Do
- Provide sound statistical guidance to clinical development, reimbursement, and medical affairs teams.
- Implement/manage standards and 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 impacting results/timelines.
- Apply regulatory guidelines in drug development.
- Stay current on innovative trial design and Amgen statistical policies/procedures/strategies.
- Contribute to process improvements and operational efficiencies.
Basic Qualifications
- Doctorate in Statistics/Biostatistics (or related, high statistical content) + 2+ years biostatistics OR
- Master’s in Statistics/Biostatistics (or related) + 4+ years OR
- Bachelor’s in Statistics/Biostatistics (or related) + 6+ years OR
- Associate’s degree + 10 years OR High school diploma/GED + 12 years.
Preferred Qualifications
- Doctorate in biostatistics/statistics.
- 5+ years pharma/biotech statistical experience.
- Life cycle drug development; cardiovascular experience.
- Leadership of multi-functional teams; strong communication and cross-cultural sensitivity.
- Statistical leadership for regulatory and reimbursement submissions.
- Strong theoretical/applied statistics and regulatory guideline knowledge.
- Experience in globally dispersed, cross-cultural teams.
Benefits (as stated)
- Retirement and Savings Plan; medical/dental/vision; life and disability insurance; flexible spending accounts; discretionary annual bonus (or sales incentive); stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com. No application deadline; applications continue until sufficient candidates are received or selected.