Senior Director, Biostatistics

Amgen-posted 7 months ago
Full-time • Senior
Remote • Washington, DC
Chemical Manufacturing
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

At Amgen, our shared mission—to serve patients—drives all that we do. As the Senior Director of Biostatistics in Biosimilar Development, you will provide strategic statistical input to and oversee all statistical aspects of biosimilar development for all products. You will lead, manage, and develop the team of biosimilars biostatisticians, oversee the performance of biostatisticians in Contract Research Organizations (CROs), and enhance statistical understanding within Biosimilar Development. Your role will involve developing innovative methodologies and study designs for biosimilars and assisting the head of Biostatistics and Statistical Programming in leading the department.

  • Provide oversight for protocols, Statistical Analysis Plans, Flash Memos/Summary of Report, Clinical Study Reports, submission documents, correspondences with health authorities, clinical publications, reimbursement documents and other communications.
  • Develop and maintain successful application of statistical excellence in design, analysis, and reporting to all phases of biosimilar development.
  • Provide strategic statistical input and is a major contributor to clinical development plans.
  • Ensure standards, technical quality and consistent approaches in clinical development strategy, study design and statistical analysis.
  • Maintain indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results.
  • Contribute to statistical strategy in Amgen's Biosimilar Development.
  • Ensure excellent statistical input into regulatory strategies, presentations and scientific reports for clinical trial, regulatory submission, product defense, market support, scientific presentation/publication.
  • Represent Biosimilar Development on statistical matters at meetings with regulatory authorities, key opinion leaders and similar other expert bodies.
  • Provide oversight and guidance to staff members within Amgen and in CROs in completing study deliverables according to agreed timelines following quality standards.
  • Responsible for hiring, allocation, management, and development of internal statistical staff.
  • Contribute to developing and managing goals, budgets and resource plans.
  • Lead and/or participate in the development and review of Policies, SOPs and other controlled documents with CROs or within Amgen's Biosimilar Development.
  • Promote, communicate, and become an expert in specific statistical methodologies.
  • Publish applied research in scientific journals and books and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings.
  • Stay abreast of and contribute to scientific advances in the field.
  • Develop and maintain long-term relationships with key statistical opinion leaders, including academics, regulators and other industry leaders.
  • Doctorate degree and 5 years of related experience OR Master's degree and 9 years of related experience OR Bachelor's degree and 11 years of related experience.
  • At least 5 years of experience directly managing people and/or leading teams, projects, or programs, preferably in learning and development, training, or a related field.
  • Ten years of post-graduate statistical experience in the pharmaceutical industry.
  • Demonstrated ability to work within a global team and with CRO partners to ensure operational excellence and efficiencies.
  • Life cycle Drug development experience (Pre-clinical Development, Clinical Development, and Post-marketing).
  • Knowledge/experience of Biosimilars development, including global regulatory requirements and design and analysis of non-inferiority and equivalence trials.
  • 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.
  • 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.
Track Jobs with Teal

Job Search Resources

•
Resume Builder
•
Resume Examples
•
Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service