Local Evidence Generation and Observational

2 months ago

Mississauga, Canada Amgen Full time

**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.

**Role: Local Evidence Generation and Observational Research Manager (12 Month Contract)**

Reports to: Country Medical Lead

Location: Mississauga Flexible Commuter

**What you will do**:
Let’s do this. Let’s change the world. In this vital role you will be working with multiple teams to generate local evidence and real-world evidence supporting a wide variety of business needs. The increasing demand for real-world evidence (RWE) from regulatory and reimbursement authorities makes observational research a key component of drug development and commercialization. Amgen Canada Inc (ACI) has an industry-leading analytical capability that generates RWE to support business needs across a product’s lifecycle.

ACI scientists partner with internal team members and industry experts to design, conduct, interpret and publish observational research that informs decision-making from the early development of a molecule to the design of clinical trials and the safety and efficacy of Amgen medicines. Observational research studies include but are not limited to evidence generation regarding the frequency and distribution of disease, the clinical burden of disease, the natural history or clinical course of disease, the design of clinical trials, treatment cost and utilization patterns, and the safety and effectiveness of therapeutic interventions.

In this role you will have responsibilities for research activities on product-facing teams for all of Amgen’s therapeutic areas. A local evidence generation and observational research manager is recognized as a strong scientific contributor and is a first or contributing author for papers in peer-reviewed journals, abstracts for scientific congresses or for internal reports that enhance the company’s mission.

**Key Activities Include**:

- Map, identify and access the best RWD (Real World Data) sources to enable RWE (Real World Evidence) tactical plan.
- Design and implement Real World Data (RWD) studies to generate Real World Evidence (RWE)
- Manage studies by liaising with external vendors, data custodians, and core study team
- Write protocols, scientific/technical manuals, statistical analytical plans, and observational study reports
- Write abstracts, posters, manuscripts and simple language summaries using the findings of an observational study
- Execute and manage research projects involving the analysis of multiple types of data including medical claims, electronic health records, and prospective observational cohort studies
- Ensure compliance to all internal and external rules regarding access to data, publication and development of observational research.
- Provide safety research support on the safety and effectiveness studies
- Conduct literature reviews and prepares research reports and scientific manuscripts
- Stay abreast of the latest developments in the field of observational research and drug development
- Promote awareness, understanding, and use of observational research methods
- Communicate scientific information to a variety of audiences

**What we expect of you**:
We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a proactive individual with these qualifications.

**Basic Qualifications**:
**Doctorate degree with 2 years of experience**:
Or

**Master's degree and 3-4 years of scientific experience**:
**Preferred Qualifications**:

- Experience in Amgen’s therapeutic areas such as cardiovascular, bone health, inflammation, rare diseases, hematology and solid tumours.
- Experience in the design, execution, and analysis of observational research studies within Pharmaceutical or Public Health setting
- Experience in research to support drug development
- Experience working with secondary data systems, including administrative claims, EMR, and registries
- Experience in observational research project planning and management
- Excellent verbal and writing communication and interpersonal skills
- Experience working in multi-disciplina

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