Biostatistics Director, Oncology Biosimilars- US Remote

Career Category ResearchJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.Biostatistics DirectorLiveWhat you will doLet’s do this. Let’s 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 publicationsStatistical leadership to regulatory submissionsDeveloping 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 Amgen’s head of Biosimilar Biostatistics and Statistical Programming guide the department.WinWhat we expect of youWe 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 experienceORMaster’s degree and 8 years of Biostatistics experienceORBachelor’s degree and 10 years of Biostatistics experienceKnowledgeable of statistical methodology and applications within drug development, including oncology clinical trialsPreferred Qualifications:Master's or Doctorate degree in Mathematics, Biostatistics or StatisticsTen 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 areaStatistical leadership to regulatory submissionsEffective communication and presentation skills including statistical strategy (written and oral)Demonstrated ability to drive innovation by implementing new methodologies and relevant statistical designsExperience 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 analysesLife 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 teamsExperience of working within a global team and with CRO partners to ensure operational excellence and efficienciesThriveWhat you can expect of usAs 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.com.Salary Range 195,228.00 USD - 237,308.00 USD Apply for the job now! Apply for this job