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. 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, 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.
Let’s do this! Let’s 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:
Preferred Qualifications:
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, we’ll 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:
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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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.
Sponsorship
Sponsorship for this role is not guaranteed.
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
217,725.00 USD - 246,888.00 USDamgen