Senior Director, Biostatistics

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION

If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Live

What you will do

Lets do this. Lets change the world.

Part of Amgens R&D Strategy & Operations organization the R&D Knowledge & Learning team serves staff across R&D and the Office of the Chief Medical Officer transforming how we learn and grow together. We are reimagining learning as an integrated longitudinal journeyinclusive of but not limited to traditional trainingby deeply understanding roles personas and the competencies needed to deliver on our goals. Through our capabilities and expertise which include learning & development knowledge management and the Amgen Library we orchestrate tailored learning experiences that drive personal and organizational growth empowering our teams to deliver on Amgens mission to serve patients around the world.

As the Senior Director of Biostatistics in Biosimilar Development provides strategic statistical input to and oversees all statistical aspects of biosimilar development for all products; leads manages and develops the team of biosimilars biostatisticians; oversees the performance of biostatisticians in Contract Research Organizations (CROs); enhances statistical understanding within Biosimilar Development; develops innovative methodologies and study designs for biosimilars; and assists the head of Biostatistics and Statistical Programming in leading the department.

Responsibilities

• 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.
• Develops and maintains successful application of statistical excellence in design analysis and reporting to all phases of biosimilar development. Provides strategic statistical input and is a major contributor to clinical development plans.
• Ensures standards technical quality and consistent approaches in clinical development strategy study design and statistical analysis; maintains indication specific standards with respect to key variables variable definitions statistical methods data structures and presentation of results; and contributes to statistical strategy in Amgens Biosimilar Development.
• Ensures excellent statistical input into regulatory strategies presentations and scientific reports for clinical trial regulatory submission product defense market support scientific presentation/publication. Represents Biosimilar Development on statistical matters at meetings with regulatory authorities key opinion leaders and similar other expert bodies and defends statistical approaches internally and externally.
• Provides 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 and contributes to developing and managing goals budgets and resource plans.
• Leads and/or participates in the development and review of Policies SOPs and other controlled documents with CROs or within Amgens Biosimilar Development for process improvement and operational efficiency.
• Promotes communicates and becomes an expert in specific statistical methodologies. Publishes applied research in scientific journals and books and gives presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings. Stays abreast of and contributes to scientific advances in the field.

• Develops and maintains long-term relationships with key statistical opinion leaders including academics regulators and other industry leaders.

Win

What we expect of you

We are all different yet we all use our unique contributions to serve patients.

Basic Qualifications

• Doctorate degree and 5 years of related experience
• OR Masters degree and 9 years of related experience
• OR Bachelors degree and 11 years of related experience

• In addition to meeting one of these educational requirements you must have 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.

Preferred Qualifications

• 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) hence knowledgeable of the processes and operations
• Demonstrated leadership attributes: charts the course develops best teams role model
• Knowledge/experience of Biosimilars development including global regulatory requirements and design and analysis of non-inferiority and equivalence trials

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

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.

• 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.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range