Biostatistics Director
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Nov 4, 2020
View more
- Discipline
- Science/R&D, Biostatistics
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
- Statistical excellence in the design, analysis and reporting for all phases of clinical development across multiple products and therapeutic areas including strategic statistical input and contributing to clinical development plans.
- Reviews product and study level documents such as clinical development plans, regulatory documents, study synopses, protocols, statistical analysis plans (SAPs), flash memos, clinical study reports (CSRs), submission documents, correspondences with health authorities, clinical publications and reimbursement documents.
- Developing and executing statistical strategy for clinical development programs ensuring standards, technical quality and consistent approaches in clinical development strategy, study design and statistical analysis while maintaining indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results.
- Ensuring excellent statistical input into regulatory strategies, presentations and scientific reports for clinical trial, regulatory submission, product defense, market support, scientific presentations/publications.
- Representing the statistical function at meetings with regulatory authorities, key opinion leaders and other expert bodies and defending statistical approaches.
- Providing oversight and guidance to Amgen staff members and CROs in completing study deliverables per agreed to timelines and quality standards.
- Hiring, allocating, leading and developing internal statistical staff and contributing to developing and managing goals, budgets and resource plans.
- Supporting the development and review of Policies, SOPs and other controlled documents with CROs or within Amgen for process improvement and operational efficiency.
- Providing subject matter expertise in statistical methodologies, publishing applied research in scientific journals and books and making presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings.
- Staying abreast of and contributing to scientific advances in the field and ensuring internal practices are current.
- Developing and maintaining long-term relationships with key statistical opinion leaders within academics, regulatory agencies and industry.
Basic Qualifications
Doctorate degree and 4 years of biostatistical experience
OR
Master's degree and 8 years of biostatistical experience
OR
Bachelor's degree and 10 years of biostatistical experience
Preferred Qualifications
- Advanced degree in Statistics/Biostatistics or other subject with high statistical content.
- Ten years post-graduate statistical experience in the pharmaceutical industry or medical research organizations with a deep knowledge of statistical methodology and applications within drug development.
- Demonstrated ability to drive innovation by implementing new methodologies and relevant statistical designs.
- Experience in statistical methodologies related to adaptive designs (e.g., group sequential design, adaptations to treatment arm selection design, Bayesian adaptive design) and/or combined phase 1/2 or phase 2/3 design.
- Statistical leadership for regulatory submissions.
- Demonstrated effective communication and presentation skills including statistical strategy (written and oral) .
- Life cycle Drug development experience (pre-clinical development, clinical development, post-marketing).
- Demonstrated leadership attributes with a proven track record in charting the course and developing high-performance teams.
- Proven background in working within a global team and with CRO partners to ensure operational excellence and efficiencies.
Join Us
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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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