Biostatistics Associate Director
- Employer
- Amgen
- Location
- Washington D.C., District of Columbia
- Start date
- Oct 26, 2024
View more categoriesView less categories
- Discipline
- Science/R&D, Biostatistics
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Biostatistics Associate Director
What you will do
Lets do this. Lets change the world. In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of, CfDA (Center for Design & Analysis). The Biostatistics Associate Director independently leads sophisticated studies and projects in the oncology therapeutic area, ensuring that the statistical aspects of clinical activities meet required standards and are robust and valid. Will also influence and supply to strategy development, participate in regulatory and routine safety submission activities, and represent GBS (Global Biostatistics Science) through participating in and collaborating with multidisciplinary project teams. Specific duties include:
Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
Implementing, managing and supporting standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
Planning and executing statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs).
Providing input for clinical publications and regulatory filing documents.
Leading all aspects of work performed by study statisticians.
Performing statistical and exploratory analysis of studies/projects and developing conclusions and recommendations.
Anticipating and communicating resource and quality challenges that could impact results or timelines.
Solid understanding of regulatory guidelines in oncology drug development.
Staying current in developments in the field of statistics in drug development (innovative trial design) and Amgens statistical policies, procedures and strategies.
Contributing to process improvements and operational efficiencies.
Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field
We are all different, yet we all use our unique contributions to serve patients. The Biostatistical professional we seek is an emerging leader with these qualifications.
Basic qualificationsDoctorate degree and 3 years ofBiostatistics experience or
Masters degree and 5 years of Biostatistics experience or
Bachelors degree and 7 years ofBiostatistics experience or
Associates degree and 12 years of Biostatistics experience or
High school diploma / GED and 14 years of Biostatistics experience
Preferred qualifications
Doctorate degree in biostatics or statistics.
6 or more years of pharma/biotech statistical experience.
Drug development experience in different stages of life cycle (pre-clinical, clinical and post-marketing).
Prior experience with oncology drug development.
Statistical experience with regulatory and reimbursement submissions.
Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influence
Strong working knowledge of theoretical and applied statistics and of regulatory guidelines.
Strong verbal and written communication combined with organizational skills.
Experience working effectively in a globally dispersed team environment with cross-cultural partners.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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