Director, Statistical Innovation

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Lets do this! Lets change the world. In this vital role you will critical expertise and leadership in the design and planning of innovative development programs and clinical trials.

Responsibilities:

Guides Product Strategy and Study Design

• Promotes innovative design options and fit-for-purpose analysis approaches that address appropriate clinical questions in protocol / program design and balance speed, quality, and cost

• Provides advisory input in the development of the Global Statistical Strategic Plan (GSSP) to align study design and statistical approaches with product strategy and Evidence Generation Plan (EGP)

• Reviews key phase 2 and 3 protocols and provides input during the TA TRC review

Provides Technical Expertise

• Provides technical expertise to GSL and EGT on innovative study designs and advanced analytical methods

• Provides design options and simulation specifications to the Simulation and Modeling team and develops and approves the simulation plan and results

• Interprets and communicates modeling and simulation results to inform and guide the selection of optimal trial designs

• Provides guidance and training to the Simulation and Modeling biostatisticians.

Builds Cross-functional Network

• Develops positive relationships with SDDs, GSLs and the Modeling and Simulation team to ensure a CfDA team approach when interacting with product teams

• Forms relationships with counterparts in EGTs to help drive the importance of Design consultation throughout the end-to-end clinical development process

• Establishes relationships with TA TRC members to ensure alignment in development strategies

Promotes the advancement of innovative designs and analysis methods

• Builds professional network with external peers in innovative designs and analysis methods

• Promotes awareness of innovative designs and analysis methods by coordinating and providing internal training sessions

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The director we seek has these qualifications.

Basic Qualifications:

• Doctorate degree and 4 years of Biostatistics/Statistical experience Or
• Masters degree and 8 years of Biostatistics/Statistical experience Or
• Bachelors degree and 10 years of Biostatistics/Statistical experience

Preferred Qualifications:

• 10 years of post-graduate statistical experience in the biopharmaceutical industry in clinical trial design, implementation, analysis and reporting
• Statistical expertise and leadership across drug development phases, regulatory submissions, and payer interactions
• Excellent computing, modelling and simulation skills using R, SAS, WinBugs, FACTS, etc. Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research
• Proven experience with both conventional and innovative trial designs (including adaptive and/or Bayesian) in different phases of drug development
• Expertise in advanced statistical analysis methods, modeling and simulation
• Knowledge of multiple disease areas and related regulatory guidelines
• Experience in leading regulatory and/or reimbursement submissions
• Strive for innovation and quick adaptation to new industry trends
• Well recognized statistical and strategic leadership among statisticians and cross-functional teams
• External visibility in biostatistics profession (e.g., through industry committees/forums, links to academia)
• Scientific research/publications in one or more areas of statistical science
• Strong technical and effective communication skills
• Managerial experience directly handling people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A 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, including remote and hybrid work arrangements, where possible

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.

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.