Director, Statistical Innovation

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

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.

Director, Statistical Innovation (DSI)

What you will do

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:

• Doctorate degree and 4 years of Biostatistics/Statistical experience Or
• Master’s degree and 8 years of Biostatistics/Statistical experience Or
• Bachelor’s 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 pr