Director, Statistical Innovation (DSI) (US - Remote)
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.
Director, Statistical Innovation (DSI)Live
What you will do
Lets do this. Lets change the world. In this vital role you will [top-line statement connecting primary position responsibility to employer brand].Job Description
Director of Statistical Innovation (DSI) provides critical expertise and leadership in the design and planning of innovative development programs and clinical trials. DSI is a key driver to ensure thorough consideration of innovative and conventional design options and selection of optimal design with scientific rigor and operational efficiency to increase the probability of success of clinical trials and the development program. DSI provides statistical leadership and consultation to the product Evidence Generation team (EGT) and the study design working group in evaluation of design options and other innovative approaches by synthesizing and interpreting simulation results and provides advisory input in partnership with the Global Development Lead (GDL), Global Statistical Lead (GSL), and Strategic Development Director (SDD).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 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.
- Develops strong partnerships with SDDs, GSLs and the Modeling and Simulation team to ensure a CfDA team approach when interacting with product teams
- Builds relationships with counterparts in EGTs to help drive the importance of Design consultation throughout the end-to-end clinical development process
- Builds relationships with TA TRC members to ensure alignment in development strategies
- Builds professional network with external peers in innovative designs and analysis methods
- Promotes awareness of innovative designs and analysis methods by organizing 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 Statistical Innovation professional we seek is a true leader with these qualifications.Qualifications
- Doctorate degree and 4 years of Statistics/Biostatistics experience OR
- Masters degree and 8 years of Statistics/Biostatistics experience OR
Bachelors degree and 10 years of Statistics/Biostatistics AND
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Masters or doctorate degree in Statistics/Biostatistics or related subjects with highly statistical content
- 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
- 5 years of strategic statistical leadership at product level of one complex program or multiple programs of moderate complexity
- 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
- Solid 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
- Drive 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 managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.
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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.