Sr Director, Statistical Innovation

Join Amgens Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared missionto serve patients living with serious illnesses drives 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

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:

• Provides senior advisory input in the design of therapeutic area and product development strategies, development programs, and clinical studies, in partnership with the Biostatistics TA head, Strategic Development Director, Senior Director-level and Director-level GSLs, EGT functional leaders, and other key stakeholders.
• Drives consideration of conventional and innovative design options and ensures the appropriate design, estimand, and estimator are selected to meet the study and development objectives.
• Provides advanced statistical and methodological advice to Senior Director-level and Director-level GSLs and other key stakeholders on complex issues that may affect major development decisions, regulatory interactions, and filings.
• Guides evaluation of design options by synthesizing and interpreting simulation results, regulatory considerations, operational feasibility, and development objectives.
• Provides design options and simulation specifications to the Simulation and Modeling team and develops, reviews, and approves the simulation plan and results.
• Connects insights and lessons across products and programs within a therapeutic area to promote consistency and broader application of innovative design and analysis approaches.

Advises Therapeutic Area and Product Strategy and Study Design

Advises Biostatistics TA leaders, Senior Director-level and Director-level GSLs leading large and complex programs, and EGTs on product strategy, development program design, and clinical study design.

Promotes conventional and innovative design options and fit-for-purpose analysis approaches that address appropriate clinical and development questions and balance speed, quality, operational feasibility, and cost.

Provides senior advisory input in the development and review of the EGP and GSSP to align program design and statistical approaches with therapeutic area strategy, product strategy, and development objectives.

Directs, applies, interprets, and communicates modeling and simulation in collaboration with the Modeling and Simulation group, the Analytics group, and other quantitative partners as needed.

Review study design options and proposals prior to submission to GDRC and Key Design Elements (KDEs) prior to submission to TA TRC.

Provides advanced technical and methodological expertise to Biostatistics TA leaders, Senior Director-level and Director-level GSLs, EGTs, and governance bodies on innovative study designs, advanced analysis…