Amgen

Biostatistics Director

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Oct 05, 2020
Ref
R-96442
Required Education
Bachelors Degree
Position Type
Full time
Amgen's Global Development Organization has an opportunity for a dynamic biostatistics director to provide strategic statistical input and oversee all statistical aspects of clinical development from early to late phase for multiple products across different therapeutic areas. Will oversee biostatisticians in Contract Research Organizations (CROs), lead, manage and develop in-house statistical staff, and assist Amgen's head of Biosimilar Biostatistics and Statistical Programming guide the department. The director will be responsible for:
  • 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.