Safety Statistician, Senior Manager

United States

Full-TimeDepends on ExperienceSenior LevelMasters

Job Description

Welcome to Amgen, a leading biotechnology company dedicated to improving the lives of patients worldwide. We are currently seeking a highly skilled and experienced Safety Statistician, Senior Manager to join our dynamic team. In this role, you will play a crucial role in ensuring the safety and efficacy of our innovative therapies. As a Senior Manager, you will lead a team of statisticians and collaborate with cross-functional teams to support clinical development programs. This is an exciting opportunity for someone who is passionate about making a difference in the healthcare industry and has a strong background in statistics. If you are a driven and detail-oriented individual with a strong understanding of safety regulations and data analysis, we encourage you to apply for this position.

Develop and implement statistical safety analyses plans for clinical development programs.
Lead a team of statisticians to ensure timely and accurate delivery of safety analyses.
Collaborate with cross-functional teams to ensure safety data is integrated into clinical development plans.
Monitor and analyze safety data from clinical trials and provide recommendations for risk mitigation.
Review and interpret safety data to identify potential safety concerns and ensure appropriate actions are taken.
Ensure compliance with all safety regulations and guidelines.
Communicate safety analyses findings to internal and external stakeholders.
Develop and maintain relationships with regulatory agencies regarding safety data.
Provide statistical support for safety assessments and regulatory submissions.
Train and mentor junior statisticians on safety analysis techniques and best practices.
Stay up-to-date with industry trends and developments related to safety statistics.
Participate in cross-functional safety teams to identify and implement process improvements.
Represent the safety statistics function in meetings and presentations.
Collaborate with other departments to ensure safety data is accurately collected and reported.
Ensure data integrity and quality control for safety analyses and reports.

Where is this job?

This job is located at United States

Job Qualifications

Advanced Degree In Statistics Or Related Field: A Minimum Of A Master's Degree In Statistics Or A Related Field Is Required For This Position.
Extensive Experience In Safety Statistics: The Ideal Candidate Should Have At Least 8-10 Years Of Experience In The Pharmaceutical Or Biotech Industry With A Focus On Safety Statistics.
Knowledge Of Regulatory Requirements: The Candidate Should Have A Thorough Understanding Of Global Regulatory Requirements Related To Drug Safety And Pharmacovigilance, Including Fda And Ema Regulations.
Leadership And Management Skills: The Senior Manager Will Be Responsible For Leading A Team Of Safety Statisticians, So Strong Leadership And Management Skills Are Essential.
Strong Analytical And Problem-Solving Skills: The Candidate Should Have A Strong Background In Statistical Analysis And Be Able To Effectively Analyze Safety Data And Identify Potential Safety Risks. Additionally, The Ability To Think Critically And Problem-Solve Is Crucial For This Position.

Required Skills

Project Management
Data Analysis
Communication
Presentation skills
Quality Control
Critical Thinking
Statistical modeling
Safety regulations
Team Leadership
Compliance Management
Risk assessment
Problem-Solving

Soft Skills

Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving

Compensation

According to JobzMall, the average salary range for a Safety Statistician, Senior Manager in United States is $110,000 - $150,000 per year. This salary range can vary depending on factors such as location, level of experience, and the specific industry or company the individual is working for. In general, those with more experience and higher levels of education and certifications may command a higher salary in this role.

Additional Information

Amgen is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedDecember 16th, 2024

Apply BeforeJune 21st, 2025

This job posting is from a verified source.

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