Biostatistics Associate Director

Career Category

Job Description

HOW 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 Associate Director

What you will do

Let’s do this. Let’s change the world. In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of, CfDA (Center for Design & Analysis). The Biostatistics Associate Director independently leads sophisticated studies and projects in the oncology therapeutic area, ensuring that the statistical aspects of clinical activities meet required standards and are robust and valid. Will also influence and supply to strategy development, participate in regulatory and routine safety submission activities, and represent GBS (Global Biostatistics Science) through participating in and collaborating with multidisciplinary project teams. Specific duties include:

• Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.

• Implementing, managing and supporting standards, technical quality and consistent approaches in strategy, study design and statistical analysis.

• Planning and executing statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs).

• Providing input for clinical publications and regulatory filing documents.

• Leading all aspects of work performed by study statisticians.

• Performing statistical and exploratory analysis of studies/projects and developing conclusions and recommendations.

• Anticipating and communicating resource and quality challenges that could impact results or timelines.

• Solid understanding of regulatory guidelines in oncology drug development.

• Staying current in developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies.

• Contributing to process improvements and operational efficiencies.

• Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field

WHAT WE EXPECT OF YOU

We are all different, yet we all use our unique contributions to serve patients. The Biostatistical professional we seek is an emerging leader with these qualifications.

Basic qualifications  

• Doctorate degree and 3 years of Biostatistics experience or

• Master’s degree and 5 years of Biostatistics experience or

• Bachelor’s degree and 7 years of Biostatistics experience or

• Associate’s degree and 12 years of  Biostatistics experience or

• High school diploma / GED and 14 years of Biostatistics experience

Preferred qualifications  

• Doctorate degree in biostatics or statistics.

• 6 or more years of pharma/biotech statistical experience.

• Drug development experience in different stages of life cycle (pre-clinical, clinical and post-marketing).

• Prior experience with oncology drug development.

• Statistical experience with regulatory and reimbursement submissions.

• Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influence

• Strong working knowledge of theoretical and applied statistics and of regulatory guidelines.

• Strong verbal and written communication combined with organizational skills.

• Experience working effectively in a globally dispersed team environment with cross-cultural partners.

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.

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

Salary Range