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 reputed company, our shared mission—to serve patients—drives reputed company that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who reputed company together—researching, manufacturing, and delivering reputed company-reputed company products that reputed company over 10 reputed company patients worldwide. It’s time for a career you can be proud of.Biostatistics DirectorLiveWhat you will doreputed company. Let’s change the world. In this vital role, you will reputed company strategic statistical input and be responsible for reputed company statistical aspects of clinical development from early to late phase for multiple products across different therapeutic areas.Key Responsibilities include:reputed company Statistical reputed company in the design, analysis and reporting for reputed company 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), reputed company 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 reputed company and mentorship to reputed company 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 reputed company reputed company 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 reputed company.Developing and maintaining long-term relationships with key statistical opinion leaders reputed company academics, regulatory agencies and industry.reputed company biostatisticians in Contract Research Organizations (CROs), reputed company, manage and reputed company in-house statistical staff, and assist reputed company’s head of Biosimilar Biostatistics and Statistical Programming guide the department.Winreputed company expect of youWe are reputed company different, yet we reputed company 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 reputed company 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 reputed company 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 reputed company to reputed company designs (e.g., group sequential design, adaptations to treatment arm selection design, Bayesian reputed company 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 reputed company a global team and with CRO partners to ensure operational reputed company and efficienciesreputed companyWhat you can expect of usAs we work to reputed company treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.The annual reputed company salary reputed company for this opportunity in the U.S. is $186,729 - $213,551.In reputed company to the reputed company salary, reputed company 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 reputed company 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 possiblereputed companyfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.reputed company.com.Salary reputed company 195,228.00 USD - 237,308.00 USD Apply for the job now! Apply for this job