Biostatistics Manager
Amgen
4 hours ago
Remote friendly (United States)
United States
Clinical Research and Development
Biostatistics Manager
Responsibilities:
- Ensure all statistical aspects of clinical activities meet required standards and are statistically correct.
- Influence study design and defend statistical approaches internally and externally; ensure strict adherence to policies, SOPs, and other controlled documents.
- Lead one complex or multiple less complex studies and projects.
- Provide statistical contributions, statistical review, and quality control for Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table/Listing/Graph (TLG) shells, Submission Data File (SDF) specifications, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications.
- Complete statistical analysis for individual studies/projects.
- Publish applied research in scientific journals/books and present statistical methodology at external meetings.
- Stay current on statistics developments in drug development and contribute to scientific advances.
- Assist with review of Amgen policies/SOPs/controlled documents; assist with study and systems audits; support change/process improvement initiatives.
Basic Qualifications:
- Doctoral degree in Statistics/Biostatistics (or other subject with high statistical content)
- OR
- Currently enrolled in a PhD program in Statistics/Biostatistics (or other high-statistical-content subject) and complete all PhD requirements prior to employment start date
- OR
- Master’s degree in Statistics/Biostatistics (or other high-statistical-content subject) and 3 years of statistics experience
Preferred Qualifications / Skills:
- Doctorate with 1 year of post-graduate statistical experience in the pharmaceutical industry or medical research.
- Strong computing, modeling, and simulation skills (R, SAS, WinBugs, FACTS, etc.).
- Experience designing, analyzing, and reporting clinical trials (pharma/biotech/public health) in industry, government, or academia.
- Experience with adaptive designs and building simulation tools.
- Knowledge of Bayesian statistics and extensive simulation/modeling knowledge.
- Ability to work with statistical colleagues and cross-functional teams; strong written and oral communication.
Benefits (Total Rewards Plan; eligibility-based):
- Health and welfare plans for staff and eligible dependents; financial plans for retirement or other goals; work/life balance; career development.
- Employee benefits including retirement/savings plan with generous company contributions, medical/dental/vision, life/disability insurance, flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales); 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 will continue until a sufficient number of applications are received or a candidate is selected.
Responsibilities:
- Ensure all statistical aspects of clinical activities meet required standards and are statistically correct.
- Influence study design and defend statistical approaches internally and externally; ensure strict adherence to policies, SOPs, and other controlled documents.
- Lead one complex or multiple less complex studies and projects.
- Provide statistical contributions, statistical review, and quality control for Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table/Listing/Graph (TLG) shells, Submission Data File (SDF) specifications, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications.
- Complete statistical analysis for individual studies/projects.
- Publish applied research in scientific journals/books and present statistical methodology at external meetings.
- Stay current on statistics developments in drug development and contribute to scientific advances.
- Assist with review of Amgen policies/SOPs/controlled documents; assist with study and systems audits; support change/process improvement initiatives.
Basic Qualifications:
- Doctoral degree in Statistics/Biostatistics (or other subject with high statistical content)
- OR
- Currently enrolled in a PhD program in Statistics/Biostatistics (or other high-statistical-content subject) and complete all PhD requirements prior to employment start date
- OR
- Master’s degree in Statistics/Biostatistics (or other high-statistical-content subject) and 3 years of statistics experience
Preferred Qualifications / Skills:
- Doctorate with 1 year of post-graduate statistical experience in the pharmaceutical industry or medical research.
- Strong computing, modeling, and simulation skills (R, SAS, WinBugs, FACTS, etc.).
- Experience designing, analyzing, and reporting clinical trials (pharma/biotech/public health) in industry, government, or academia.
- Experience with adaptive designs and building simulation tools.
- Knowledge of Bayesian statistics and extensive simulation/modeling knowledge.
- Ability to work with statistical colleagues and cross-functional teams; strong written and oral communication.
Benefits (Total Rewards Plan; eligibility-based):
- Health and welfare plans for staff and eligible dependents; financial plans for retirement or other goals; work/life balance; career development.
- Employee benefits including retirement/savings plan with generous company contributions, medical/dental/vision, life/disability insurance, flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales); 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 will continue until a sufficient number of applications are received or a candidate is selected.