Biostatistics Director, Oncology Biosimilars- US Remote

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 Director Live What you will do Lets do this. Lets change the world. In this vital role, you will provide strategic statistical input and be responsible for all statistical aspects of clinical development from early to late phase for multiple products across different therapeutic areas. Key Responsibilities include: • Lead 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, and clinical publications • Statistical leadership to regulatory submissions • Developing and execution of 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 specialist bodies and defending statistical approaches. • Providing oversight and mentorship to Amgen staff members and CROs in completing study deliverables per agreed to timelines and quality standards. • 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. • Oversee biostatisticians in Contract Research Organizations (CROs), lead, manage and develop in-house statistical staff, and assist Amgens head of Biosimilar Biostatistics and Statistical Programming guide the department. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Biostatistics Director we seek is a project leader with these qualifications: Basic Qualifications: Doctorate degree and 4 years of Biostatistics experience OR Masters degree and 8 years of Biostatistics experience OR Bachelors degree and 10 years of Biostatistics experience Knowledgeable of statistical methodology and applications within drug development, including oncology clinical trials Preferred Qualifications: • Master's or Doctorate degree in Mathematics, Biostatistics or Statistics • 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, especially in the oncology therapeutic area • Statistical leadership to regulatory submissions • Effective communication and presentation skills including statistical strategy (written and oral) • 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), combined phase 1/2 or phase 2/3 design, or Bayesian analyses • Life cycle Drug development experience (pre-clinical development, clinical development, post-marketing) • Demonstrated leadership attributes with a track record in charting the course and developing high-performance teams • Experience of working within a global team and with CRO partners to ensure operational excellence and efficiencies Thrive 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. The annual base salary range for this opportunity in the U.S. is$186,729 - $213,551. In addition to the base salary, 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 Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Apply tot his job