Biostatistics Director, Oncology Biosimilars- US Remote

About the Position

Biostatistics Director, Oncology Biosimilars - US Remote

Amgen is seeking a Biostatistics Director for Oncology Biosimilars to join our team in a remote role. This position offers an exciting opportunity to lead statistical excellence in clinical development from early to late phases.

Responsibilities

• Develop and maintain successful application of statistical excellence in design, analysis, and reporting for all phases of biosimilar development across multiple products and therapeutic areas.
• Review product and study level documents such as clinical development plans, regulatory documents, study synopses, protocols, statistical analysis plans (SAPs), clinical study reports (CSRs), submission documents, correspondences with health authorities, and clinical publications.
• Responsible for hiring, allocation, management, and development of internal statistical staff, and contributes to developing and managing goals, budgets, and resource plans.
• Develop and execute statistical strategy for clinical development programs ensuring standards, technical quality, and consistent approaches in clinical development strategy, study design, and statistical analysis.
• Provide oversight and mentorship to Amgen staff members and CROs in completing study deliverables per agreed timelines and quality standards.
• Represent the statistical function at meetings with regulatory authorities, key opinion leaders, and other specialist bodies and defend statistical approaches.
• Stay abreast of and contribute to scientific advances in the field and ensure internal practices are current.
• Develop and maintain long-term relationships with key statistical opinion leaders within academics, regulatory agencies, and industry.

Requirements

• Doctorate degree and 4 years of Biostatistics experience
• Master’s degree and 8 years of Biostatistics experience
• Bachelor’s degree and 10 years of Biostatistics experience

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.
• Knowledgeable of statistical methodology and applications within drug development.
• Statistical leadership for regulatory submissions.
• 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.
• 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 track record in charting the course and developing high-performance teams.
• Background in working within a global team and with CRO partners to ensure operational excellence and efficiencies.

We Offer

• Competitive salary range: $200,108.70 - $270,735.30 USD
• 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.
• Flexible work models where possible.

About the Company

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions, and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Apply Now

Apply now and make a lasting impact with the Amgen team.

Attention Job Applicants

At Amgen, we are relentless in applying the highest ethical standards to our products, services, and communications. Consistent with this, we expect all job applicants to act with honesty and integrity. Providing any false or misleading information, or omitting material information during the hiring process, may result in immediate disqualification from the hiring process or termination if already employed. We appreciate your cooperation in helping us uphold these standards.

Sponsorship

Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex, or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.