
Safety Statistician, Senior Manager
Welcome to Amgen, a leading biotechnology company dedicated to discovering, developing and delivering innovative medicines to patients worldwide. We are currently seeking a highly skilled and experienced Safety Statistician, Senior Manager to join our dynamic team. As a key member of our Safety organization, you will play a critical role in ensuring the safety of our products and patients. This position requires a strong statistical background, excellent analytical skills, and the ability to effectively communicate complex data to various stakeholders. If you are passionate about making a meaningful impact in the pharmaceutical industry and have the qualifications we are looking for, we invite you to apply and join our mission to serve patients and advance science.
- Conduct statistical analyses to support safety evaluations of Amgen products.
- Collaborate with cross-functional teams to design and implement statistical methods for safety data analysis.
- Develop and maintain safety statistical analysis plans and protocols.
- Utilize advanced statistical techniques to analyze and interpret safety data.
- Communicate complex statistical findings to non-technical audiences, including senior management and regulatory agencies.
- Ensure compliance with regulatory requirements and internal standards for safety reporting and analysis.
- Monitor safety data and identify potential safety signals, and provide recommendations for further investigation.
- Participate in the development and implementation of safety risk management plans.
- Support safety surveillance activities, including data mining and signal detection.
- Provide statistical expertise for safety-related submissions to regulatory agencies.
- Train and mentor junior statisticians on safety data analysis techniques and methods.
- Keep up-to-date with industry trends and developments in safety statistics and contribute to continuous improvement efforts within the Safety organization.
- Collaborate with external partners and vendors to ensure accurate and timely delivery of safety data.
- Maintain a high level of quality and accuracy in all safety statistical analysis activities.
- Represent Amgen in scientific conferences and contribute to publications in the field of safety statistics.
Advanced Degree In Statistics Or A Related Field, Such As Biostatistics Or Data Science.
Minimum Of 8-10 Years Of Experience In Statistical Analysis And Data Management Within The Pharmaceutical Or Biotechnology Industry.
In-Depth Knowledge Of Regulatory Requirements And Guidelines Related To Safety Reporting, Such As Fda And Ema Guidelines.
Strong Leadership And Project Management Skills, With Experience In Managing A Team Of Statisticians And Overseeing Multiple Projects Simultaneously.
Excellent Communication And Collaboration Skills, With The Ability To Effectively Communicate Complex Statistical Concepts To Non-Technical Stakeholders And Work Cross-Functionally With Other Departments.
Process Improvement
Communication Skills
Project Management
Data Analysis
Quality Control
Statistical modeling
Team Leadership
Compliance Management
Risk assessment
Problem-Solving
Regulatory Knowledge
Safety Monitoring
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Safety Statistician, Senior Manager in Washington, DC, USA is between $120,000 and $180,000 per year. However, this can vary depending on factors such as experience, education, and the specific company or organization the individual is employed by. Additionally, location within Washington, DC can also play a role in salary range.
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Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.

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